Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The device's labelling inaccurately indicates “endotracheal” as a body temperature application site. the flextemp reusable temperature sensor is not intended to be used for endotracheal site placement.
Action
Philips is advising end users that the FlexTEMP reusable temperature sensor cannot be in endotracheal site. Philips is working to correct this labelling issue and will contact customers with an update on its implementation plan. This action has been closed-out on 09/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens healthcare diagnostics is issuing a field correction for a change in the concentration of n-acetylcysteine (nac) that may cause interference for the advia chemistry systems acetaminophen assay current lots and all future lots. the previous maximum nac concentration at which acceptable acetaminophen results were obtained was 800 mg/l. siemens has revised the concentration of nac at which acceptable results were obtained to 200 mg/l nac in an acetaminophen sample of approximately 661 µmol/l (10 mg/dl).
Action
Siemens is advising end users of the change in the instructions for use regarding interference caused by NAC. The Instructions For Use (IFU) will be updated to reflect this change in interference.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Siemens has recently discovered a potential miscalculation when using the doppler manual trace measurement tool in a full screen display format. the manual trace tool may incorrectly calculate the time average velocity (tav) and subsequently incorrectly calculate the pulsatility index (pi). the potential risk is a misdiagnosis however, the probability is low.
Action
This issue will be resolved in a future software release. In the interim to avoid this issue, users are advised not to perform measurements utilising the manual Doppler trace tool in a full screen display format. This action has been closed-out on 15/02/2017.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Convatec is conducting a recall (tga ref no: rc-2015-rn-00514-1) of various sized unomedical branded suction tubes. the tubes are being recalled as the connector on the tubes has a probability of cracking once it is applied to suction device ports.Multigate is issuing this notice to your hospital as you have received the above custom procedure packs (cpp) where you have specified the inclusion of the unomedical suction tube that is now subject to this recall.
Action
Multigate requesting end users to stop using the affected CPP. Multigate will supply replacement sterile tubing as for all the affected stock. Once replacement tubing is received end users are required to replace the defective tube with the sterile replacement product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
A portion of the affected lot contains units with an incorrect compliance card affixed to the catheter hoop inside the product pouch. specifically, the incorrect 7mm compliance card contains the incorrect balloon diameter, lengths, diameter growth (compliance), and rated burst pressure (rbp) information instead of the correct 6mm compliance card.
Action
End users are advised of the labelling issue and provided with the correct compliance card. Bard is recommending that the affected stock is isolated and that this letter is placed in a prominent positon with the isolated stock.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Customer reported an issue with a failing monitor ceiling suspension (mcs) actuator of an allura xper system. the actuator assembly had become detached and the monitor carriage with a flexvision monitor dropped to its lowest position. the monitor ceiling suspension is designed to allow flexible positioning near the patient table when in use, and away from the patient when not in use (park position).When the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room. there is also the possibility that the monitor ceiling suspension collides with other equipment in close proximity of the mcs.
Action
Philips will check if the actuator serial number is on the affected product list. If the actuator is on the affected product list the immediate containment action is to secure the MCS with straps to prevent the monitors to fall down in case the actuator fails. Actuators on the affected products will be replaced by Philips. In order to avoid any risk for patients, users or bystanders Philips recommend the following until the containment action FCO has been implemented:
- Do not position or move the Monitor Ceiling Suspension above the patient.
- Do not allow staff to stand under or close to the Monitor Ceiling Suspension.
Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
An internal assessment of convatec’s product complaints has confirmed that these devices are not meeting their expectations or those of our customers. specifically, the connector part for application to the suction devices in these lots, has failed to meet its required reliability. suction tubes are intended to connect a suction device, such as a suction catheter or suction handle, to a vacuum unit. suction tubes are equipped with multi-purpose connectors that are designed to fit many suction devices and outlets. the connector parts of the specified lots have a higher probability to crack once applied to suction devices outlets.
Action
Medline is requesting end users to remove and discard the Unomedical Suction Tubing from the procedure pack at the time the scrub nurse prepares for the surgery. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Ortho clinical has received two complaints:1) when a customer installed the add that supported the new vitros chemistry products hba1c reagent kit, the vitros 5,1 fs system posted the two condition codes ua7-239 and syd-024. the condition codes occurred because the short assay name for the new vitros assay had the same name as a user defined assay currently in use on their vitros 5,1 fs system. as a result, the user defined assay target was deleted from their system.2) when a customer installed the add, their system became unresponsive (screen freeze occurred) that required the vitros 5,1 fs system to be restarted; the system posted condition code uz0-047 after the restart was initiated.Due to a software coding error, for both scenarios, all default settings were restored from the add instead of retaining the user modified (configured) parameters and the operator was not alerted by the system.
Action
OCD has determined that the root cause of this anomaly is due to an error in the software code. The resolution is currently under development and will be available in a future version of software. In the interim, OCD has provided workaround instructions to assist end users mitigate this issue. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
A problem exists in mosaiq resulting in the incorrect field size being sent to the treatment machine for stereotactic plans. when a stereotactic field is imported or promoted, and the treatment field definition is opened:- the mlc shape will be correct for the planned cone field size, and- the user will also see the field size displayed with x=40 and y=the jaw setting for the planned cone. if simple mlc is selected, without changing the jaw size, the mlc shape will move the virtual x jaw to its most retracted position of 40. when the user clicks “ok” to accept the field change, they are presented with the field delta window and they must click “accept” for the change to take effect. if the mlcs are not edited to return to the correct shape for the planned cone, the user can unintentionally save the virtual jaw settings as the mlc shape resulting in a treatment field much larger than intended. the problem occurs because simple mlc is resetting the mlc positions.
Action
The problem can be avoided by clicking Cancel on the Create Simple MLC window, editing the field size values in the Create Simple MLC window to return to the correct MLC shape for the planned cone before saving or by not using the Simple MLC view. This problem will be resolved in a future release of the current MOSAIQ versions 2.41, 2.50, 2.60, 2.62. Elekta will inform the affected customers when the relevant MOSAIQ build is released containing the fix. This action has been closed-out on 8/08/2016,
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
This issue occurs when using the civco biopsy attachments in combination with the acuson s family on-screen guidelines. the biopsy needle may traverse outside the on-screen guidelines. this occurs on the 6c1 hd and 18l6 hd transducers. the potential risk is the tissue of interest may not get sampled. to date, no patient injury has been reported.
Action
To avoid this issue, users are advised not to use the 6C1 HD and 18L6 HD with the CIVCO biopsy attachments for guided biopsy procedures.
For guided procedures with other transducers, users are advised that they must verify that the path of the needle is accurately indicated by the on-screen guidelines. The needle guide is ready for patient use only after the path of the needle has been verified.
Also, users are reminded of the following warnings:
- The biopsy guidelines that display on the system monitor are not intended as an absolute reference. It is the user's responsibility to verify correct positioning of the needle during a biopsy or puncture procedure.
- Do not use a needle guide if the path of the needle is not accurately indicated by the
on-screen guidelines. The path of the needle must display within the guideline.
Users are advised to contact their Siemens service representative if the needle path is not accurately indicated.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Dräger has become aware of an event in which the battery capacity of the optional ps500 did not last as long as expected. the batteries installed in the ps500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. in 2014, dräger issued a measure regarding similar battery capacity failures within the ps500 external power supply unit. the root cause for that instance of the reduced battery capacity was due to an incorrect charging algorithm that subsequently caused sulfation within the battery. dräger have now identified that the new batteries supplied during this exchange may be affected by a manufacturing defect that could lead to shorter battery life times. the current analysis of the battery data available indicates that the charged battery will at least last for 30 minutes. in case of a main power loss, this 30 minutes battery back-up should typically be sufficient until the emergency main power supply is re-established.
Action
Affected customers will be contacted by Dräger representative to organise a battery exchange as soon as possible. Until the new batteries are installed Dräger is strongly recommending the following:
- Do not rely on the battery status indicator.
- If power fail alarm occurs, provide manual ventilation and immediately connect the ventilator to mains power to resume ventilation.
- If the hospital’s Dräger ventilators are currently used for patient transport please contact Drager Service representative immediately so that these devices will be put on priority for the battery exchange.
- Do not use the device for patient transports, unless absolutely necessary. This action has been closed-out on 22/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Artis system has an x-ray locking function that prevents any accidental release of radiation. if the systems enters "bypass fluoro" mode while the x-ray locking function is active a system error can occur which makes it impossible to exit the locking function without restarting the system or resolving the cause of the "bypass fluoro".In the situation described, no radiation is possible and no fluoroscopic images can be acquired.
Action
Siemens is developing a software patch to ensure that the Artis system automatically unlocks the radiation release in "Bypass Flouro" mode. This will ensure that imaging is possible in all cases. This action has been closed-out on 22/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
The automatic monitor units (mu) calculation (normalisation) might be incorrect in the brainlab iplan rt dose versions 4.0 and 4.1 if all of the following conditions are met: - several ptvs are planned in the treatment plan, and - at least one treatment group or treatment element is locked to prevent further modification, and - for any ptv with a locked treatment group or with at least one locked treatment element assigned the dose at the 50% volume constraint point deviates more than 5% from the actual dose at 50% volume.If the mu calculation is refreshed, the software will always normalise the dose of the ptvs, which do not have a locked treatment group or treatment element assigned, to the 50% volume constraint point. other constraint points for the ptvs will be disregarded even if a constraint point is set “hard constraint” and therefore the intended prescription will not be automatically fulfilled for ptvs without a locked treatment group or locked treatment element.
Action
Brainlab will provide a software solution to prevent the described scenario from occurring. Brainlab will actively contact affected customers starting January 2016 to schedule the update. This action has been closed-out on 12/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
When performing a 2d stress echo study, specific keystrokes may result in a potential loss of data, where some selected clips may not be saved as part of the study. the potential risk is that the stress echo study may need to be performed again.
Action
Siemens is providing users with interim instructions to follow. A software update will be provided to affected users, which will resolve the issue. This action has been closed-out on 05/12/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Radiometer has recently become aware that the storage temperature range for the combi m sensor 82 printed in the operators manual for microgas 7650 is incorrect. the operators manual states that the storage temperature range is -40c to +70c when it should be -10c to +50c as per the information supplied with the product.
Action
Radiometer is reiterating instructions on how to verify the performance of the sensor. An addendum to the instructions for use is also being provided with the correct storage conditions. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Depuysynthes reported that the ria drive shaft, tube assembly, and reamer head have the potential to break when incorrectly assembled or used improperly as follows: - failure to fully engage the reamer to shaft at assembly prior to surgery. incorrect assembly creates a reduced reamer/shaft contact surface area, in which excess rotational forces could cause breakage- use of ria drive shafts after the flats have become worn and rounded - use of any excess force beyond design limit - use with an incompatible power tool. precautionary statements are being added to the reamer / irrigator / aspirator (ria) surgical technique guide.
Action
DePuySynthes is requesting the customers to download the updated Surgical Technique Guide (036.000.553). from Synthes website at:- http://syntheskyo.com/global_trauma_kyo/home/home.htm or contact their DePuy Synthes Representative for a hardcopy. This action has been closed-out on 05/12/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Between may 2012 and july 2014, ondal medical systems gmbh received three complaints from customers where a broken joint of the articulated arm was reported. for two of the complaints the parts failed directly after installation of the device, for the other complaint, the part failed after six months. the load attached to the arm was in all three cases was approximately 18 kg.Additional inspection is required because there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in a potential failure of the arm joint.
Action
Stryker is requesting hospitals to check all stock areas and/or operating room storage and quarantine all affected equipment. A Stryker Representative will contact your facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera. This action has been closd-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
A customer complaint identified that a triathlon tibial bearing insert cs x3 size #2 9mm (5531-g-209) was reported to be incorrectly packaged and labelled as a triathalon cr size #2 9mm insert (5530-g-209).Although a delay in surgery of 10 minutes was reported in the complaint, no actual harm was reported.
Action
Users are asked to inspect stock on hand and quarantine any affected units. This action has been closed-out on 05/09/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Abbott diagnostics division has determined that during the manufacture of the architect b12 reagent kits (list 7k61) listed below, an incorrect ifu (instructions for use) commodity number g3-0354/r04 may have been inserted into the reagent kits. there is no impact to patient safety.
Action
If the incorrect IFU is detected, customers are requested to download the correct IFU from the following website located on the ARCHITECT B12 reagent kit label: - www.abbottdiagnostics.com/IFU. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Extra notes in the data
Reason
Q core (the sapphire infusion pump original manufacturer) has received complaints from customers that when using the epidural mode with patient bolus, the amount of medication delivered may be greater than programmed. in the sapphire pump, as in all infusion systems, external factors may cause fluctuations in flow rate accuracy. investigation of these complaints determined that the deviation observed is exclusively related to the use of catheters with a gauge smaller than that used for the sapphire pump flow accuracy calibration. no patient injuries or deaths have been reported as a result of this issue.
Action
To address this issue, Q Core Medical is providing an addendum to the User Manual to assist customers in (i) identifying whether the catheter utilized may cause over-delivery, (ii) better understanding the effect of back pressure and catheter size on the accuracy of the delivered volume, (iii) translating the catheter’s back pressure to the degree of flow deviation that can be expected, and (iv) contacting Hospira Representative to determine if and to what extent specific catheter/pump combinations are susceptible to over-delivery.
Future versions of the User Manual will incorporate the information contained in the addendum. This action has been closed-out on 30/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
If a position sensor fault in the swivel base axis is not detected by the system software, the c-arm system may move faster than normal when movement is enabled by the operator. the system will not move of its own accord, movement must still be initiated by the operator, however the system can unexpectedly exceed its usual speed, potentially resulting in a collision. there have been no complaints from australian customers regarding this issue.
Action
This issue will be remedied with software update AX037 /15/S (Patch 2). Following the installation of this update, the speed of the C-arm will be limited to a pre-determined level. This action has been closed-out on 12/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Philips has identified these issue with the tumorloc software1) when a single contour is saved in edit mode, tumorloc does not save the contour in the correct location. the contour is saved in the location of the same slice where the last contour was drawn for the last region of interest (roi) in the roi list. a misplaced contour then results in a misplaced isocenter or incorrect field size. 2) when the region of interest (roi) is displayed on the beam’s eye viewer (bev) in outline mode, and the roi colour is changed, the colour is changed in the multi-planar projection (mpr) viewers but not the bev viewers. 3) tumor loc-created datasets are flipped and incorrectly labelled when non-gated data is loaded along with pulmonary gated data and is used to create intensity projection datasets (mip, minip, or avgip).4) duplicate roi or isocenter names can be created in tumor loc. this duplication is only possible when using the copy feature or manually naming a roi with the suffix copy.
Action
A Philips Field Service Engineer will implement the Tumor LOC software upgrade to the affected system. In the interim, users are advised to implement workarounds to prevent the failure mode from occurring. This action has been closed-out on 15/08/2016.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Perkin elmer has become aware that the stability of the plgf calibrators lot 637341 is impaired. the stability issue is limited to one lot of plgf calibrators. due to the impaired stability a decreasing trend in the signal level measured for the plgf calibrators occurs; the signal level of the plgf calibrators lot 637341 has decreased an average of 20% since release. the signal decrease results in the measured plgf concentrations for the qc controls and patient samples will be falsely high, expected increase is approximately +20%. perkin elmer investigations have identified the impaired stability of the plgf calibrators is due to an issue in the quality of a single batch of the raw material used in the manufacture of the plgf calibrators.
Action
Perkin Elmer is requesting the customers to check their inventory, immediately discontinue use and destroy all the affected DELFIA Xpress PlGF kit lots. PerkinElmer will replace all DELFIA Xpress PlGF Kits of the designated lots in the inventory. Perkin Elmer is further requesting the customers to review and repeat patient samples, if PlGF control values for completed DELFIA Xpress PlGF runs with the affected product lots are not within the established acceptance range. This action has been closed-out on 04/05/2017.
Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Lebanon.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
Extra notes in the data
Reason
Issue 1 – users could inadvertently extend the blood glucose timestamp for a given blood glucose value by 12 minutes leading to a potentially incorrect bolus dose calculation. medtronic is currently not aware of any malfunctions, complaints, adverse effects, disease, illness, injuries or confirmed deaths related to this issue; andissue 2 – the ‘max bolus exceeded’ & ‘high/low’ blood glucose notification warning pop-ups for the bolus wizard software are not timing out which may lead to confusion. there are no reported harms due to the combination of potential user error and pop up screens not timing out.
Action
Medtronic has updated the user guide to rectify this issue. For more details, please see https://www.tga.gov.au/alert/minimed-640g-insulin-pump. This action has been closed-out on 15/08/2016.