Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: lifescan onetouch verio pro, onetouch verio iq, and onetouch verio pro+ blood glucose meters
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning onetouch verio pro, onetouch verio iq, and onetouch verio pro+ blood glucose meters, manufactured by lifescan.
regarding onetouch verio pro and onetouch verio pro+, at blood glucose levels of 33.3 mmol/l] and above, the meter should display a warning that says “extreme high bg above [33.3 mmol/l].” however, at extremely high blood glucose levels of [56.8 mmol/l] and above, the meters will display and store in memory an incorrect test result that is [56.8 mmol/l] below the measured result.
regarding onetouch verio iq, at extremely high blood glucose levels of 56.8 mmol/l and above, the meter will turn off instead of displaying the message “extreme high glucose above 33.3 mmol/l” as intended. when turned back on, the meter enters the set-up mode and requires the user to confirm the date and time settings before being able to test again. however, if the glucose level is still 56.8 mmol/l or above when testing, the meter will shut down again.
both of the above situations can cause delay in the diagnosis of severe hyperglycemia. the manufacturer advises patients to discontinue use of this meter immediately and use another meter for testing their blood glucose. furthermore, lifescan will be conducting a global recall to remove all of the affected meters from the market.
according to the local supplier, the affected products were not distributed in hong kong.
for details, please refer to mhra website
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con249653
if you are in possession of the product, please contact your supplier for necessary actions.
posted on 26 march 2013.
French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
ANSM has been informed by LifeScan about the implementation of a withdrawal of products concerning OneTouch Verio IQ blood glucose meters. The attached letter (27/03/2013) (71 KB) must be sent to the users concerned. This information is addressed to the directors of health establishments, local reactive vigilance correspondents, health professionals (doctors, pharmacists) and patients.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: abbott diabetes care freestyle insulinx blood glucose monitoring system
the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning freestyle insulinx blood glucose monitoring system, manufactured by abbott.
abbott has determined that at extremely high blood glucose levels of 56.8 mmol/l and above, the freestyle insulinx meter will display and store in memory an incorrect test result that is 56.8 mmol/l below the measured result. for example, a blood glucose value of 59.1 mmol/l will be displayed and stored as a value of 2.3 mmol/l (59.1 mmol/l–56.8 mmol/l = 2.3 mmol/l).
if the freestyle insulinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia, or incorrect treatment may be given.
product recall and replacement is on-going from distributors and health care providers. the affected patients are advised to update the software on the affected meters immediately, or they can contact their local abbott diabetes care customer service for assistance.
according to the local supplier, abbott diabetes care, the affected product has not been distributed in hong kong.
for details, please visit the following mhra website:
http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/
fieldsafetynotices/con261768
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 16 april 2013.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Extra notes in the data
Action
Possibility of obtaining incorrect results with the blood glucose meters "FreeStyle InsuLinx", manufactured by Abbott Diabetes Care USA, in the presence of extremely high blood glucose concentrations of 1024mg / dL or higher.
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
Extra notes in the data
Reason
At extremely high blood glucose levels of 56.8 mmol/l and above, the meter will display and store in its memory an incorrect low test result.
an incorrect low result may delay a diagnosis of diabetic ketoacidosis and suggest an incorrect insulin dose.
the manufacturer has published a field safety notice on this problem dated 15 april 2013.
there are no other abbott diabetes care products affected by this issue.
the performance of the test strips is not affected by this problem.
the meter is capable of reporting results in the range 1.11 to 27.78 mmol/l.
a communication has been sent out by the manufacturer to customers, healthcare professionals and pharmacists detailing the issue.
Action
Healthcare professionals to immediately discontinue supplying these meters and return any unused meters to your supplier.
Healthcare professionals and pharmacists to advise users to either:
download new software through the Auto-Assist computer application supplied with the meter
or
obtain a replacement meter by contacting Abbott Diabetes Care Customer Service (0800-088-5521).
Pharmacists supplying FreeStyle Lite blood glucose test strips advise users with FreeStyle InsuLinx meters to either:
upgrade their meters by downloading and installing new meter software through the Auto-Assist personal computer application supplied with the meter. When connected, users will be prompted to upgrade where required. A link to the website www.freestyleinsulinx.com/swupdate is provided in the communication to customers, healthcare professionals and pharmacists
or
contact Abbott Diabetes Care Customer Service to obtain a replacement meter (0800-088-5521).
Meters with the updated software are marked with a yellow circle on the carton near the lot number.
Healthcare professionals who manage patients who use FreeStyle InsuLinx meters:
Identify patients who are using these meters.
If you have FreeStyle InsuLinx meters in your current stock contact Abbott Diabetes Care customer care for replacements.
Advise users of FreeStyle InsuLinx meters to either:
upgrade their meters by downloading and installing new meter software through the Auto-Assist personal computer application supplied with the meter. When connected, users will be prompted to upgrade where required. A link to the website www.freestyleinsulinx.com/swupdate is provided in the communication to customers, healthcare professionals and pharmacists
or
contact Abbott Diabetes Care Customer Service to obtain a replacement meter (0800-088-5521).
Meters with the updated software are marked with a yellow circle on the carton near the lot number.
Healthcare professionals who manage patients who use this device.
Pharmacists supplying FreeStyle Lite blood glucose test strips.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Extra notes in the data
Advice regarding a device removal. 3rd Party Publications
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Recall of certain lots of freestyle and freestyle lite blood glucose test strips
the department of health (dh) today (november 25) drew public attention to abbott diabetes care's recall of certain lots of its two brands of blood glucose test strips, namely freestyle and freestyle lite, due to the potential for giving erroneously low blood glucose results when using in conjunction with certain brands of blood glucose meters also manufactured by the company.
the dh, through its routine surveillance on medical devices, noticed a recall notice issued by the therapeutic goods administration (tga) of australia involving two lots of freestyle lite blood glucose test strips (lot number: 1366540 and 1366621).
according to tga, the two affected lots have the potential to give readings that are incorrectly low when used in conjunction with freestyle papillon mini blood glucose meters.
when conducting follow-up to tga's alert, dh noticed that abbott diabetes care in the us has posted a recall notice on its company website, announcing that certain lots of freestyle and freestyle lite blood glucose test strips (lot numbers: 1281732, 1283345, 1283603, 1285007, 1350414, 1363015, 1363109, 1363321, 1365056, 1365920, 1365921, 1365934, 1366006, 1366111, 1366337, 1366347, 1366515, 1367917, 1373262 and 1374907) may also produce falsely low blood glucose results when they are used with freestyle blood glucose meters, freestyle flash blood glucose meters and the freestyle blood glucose meter built into the omnipod system.
a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia.
"although preliminary enquiry with the local supplier, abbott laboratories limited, reveals no evidence of the affected products having been distributed in hong kong, a public alert is justified as there may be patients in the territory who have obtained the devices or test strips from abroad or from internet purchase," the spokesman remarked.
"dh will continue to follow up with the supplier to further verify whether other brands and lots are affected and their distribution," the spokesman said.
so far, the dh has not received any local report of adverse events arising from use of the affected products.
people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman urged.
the company has set up a customer service hotline 5808 4196 to answer related enquiries.
ends.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Extra notes in the data
Reason
The irish medicines board (imb) has been notified that certain lots (lot numbers 1284962 and 1372611) of freestyle lite® blood glucose test strips may give erroneously low blood glucose results and may produce out of range control solution results when using freestyle® blood glucose meters, freestyle mini® blood glucose meters and the freestyle® meter built into the omnipod® system.
Action
Advice for End Users / Patients:
1. Identify any test strips from the affected lots.
2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).
3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 008000 2255 232 or 1800 776633 for a replacement of the affected test strips.
4. Ensure that you can continue to appropriately monitor your blood glucose via test strips from a different lot number or by other means. This should be done in consultation with your healthcare professional.
• Pay special attention to signs and symptoms of high blood sugar (hyperglycemia).
• Symptoms of high blood sugar may include: Excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are experiencing any of these symptoms or are not feeling well, contact your health care professional immediately. Advice for Healthcare Professionals / Pharmacists / Distributors:
1. Identify any test strips from the affected lots.
2. Follow the manufacturer’s instructions outlined in the attached field safety notices (FSNs).
3. Discontinue use and dispose of test strips from the affected lots and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement of the affected test strips.
4. Ensure that the appropriate personnel are made aware of this notice and the attached field safety notices. Please also pass this notice and the attached FSNs on to any end user or organisation where the potentially affected test strips have been transferred.
5. Ensure that end users who dispose of blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Extra notes in the data
Source: FSCA
Reason
Device failure / feature before use - manufacturing.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Extra notes in the data
Source: M2
Reason
Device failure / feature before use - manufacturing.
Danish data is current through March 2019. All of the data comes from the Danish Medicines Agency, 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 data from the U.S. and Denmark.
"Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
Extra notes in the data
Reason
The irish medicines board (imb) has been notified that freestyle mini® blood glucose meters and freestyle® blood glucose meters may give erroneously low blood glucose results and may produce out of range control solution results when using freestyle lite® and freestyle® blood glucose test strips.
Action
Advice for End Users / Patients:
1. Follow the manufacturer’s instructions outlined in the attached FSN and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement meter.
2. Ensure that you can continue to monitor your blood glucose appropriately. This should be done in consultation with your healthcare professional.
3. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). Symptoms may include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are
experiencing any of these symptoms or are not feeling well, contact your healthcare professional immediately.
Advice for Healthcare Professionals / Pharmacists / Distributors:
1. Follow the manufacturer’s instructions outlined in the attached FSN and contact Abbott Diabetes Care Customer Service on 1800 776633 for replacement meters.
2. Ensure that end users who dispose of affected blood glucose meters can continue to appropriately monitor their blood glucose.
3. Ensure that the appropriate personnel are made aware of this notice and the attached FSN. Please also pass this notice and the attached FSN on to any end user or organisation where the potentially affected blood glucose meters have been transferred.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Press release
Reason
Recall of certain brands of abbott diabetes care blood glucose monitoring systems
the department of health (dh) today (february 28) drew public attention to the recall by abbott diabetes care of certain brands of its blood glucose monitoring systems which may produce inaccurate glucose results.
the dh received the above safety alert from the local supplier, abbott laboratories limited. the manufacturer, abbott diabetes care, has identified through internal testing and investigation that certain brands of their blood glucose monitoring systems, namely freestyle, freestyle flash, freestyle papillon, freestyle mini, freestyle papillon mini, optium mini blood glucose meters, freestyle navigator continuous glucose monitoring system and freestyle blood glucose meter built into the omnipod insulin management system, have the potential to produce erroneously low blood glucose results when used in conjunction with any freestyle test strip.
a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia.
so far, the dh has not received any local report of adverse events arising from use of the affected products.
people who are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman added.
the company has set up a customer service hotline 5808 4196 to answer related enquiries.
ends/friday, february 28, 2014.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 data from the U.S. and Germany.
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.
Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
Extra notes in the data
Medical Device Safety Alert
Reason
Medical device safety alert: arkray factory inc spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip
the united states food and drug administration (fda) has issued an alert concerning the spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip [lot numbers: pn5c26 and ea4m78; manufacturing dates: november 2014 to september 2015; distribution dates: 18 february 2015 to 13 october 2015], manufactured by arkray factory inc.
according to the fda, the manufacturer is recalling the spotchem ii basic panel-1 reagent test strip and spotchem ii glucose reagent test strip because they may report falsely low blood glucose levels when the true levels are above 265 mg/dl.
there is a risk that the health care provider would not diagnose hyperglycemia (high blood sugar) including diabetic ketoacidosis and hyperosmolar hyperglycemic syndrome in a timely manner and fail to treat elevated blood glucose levels. the issue may cause serious injury or death.
the manufacturer sent an urgent medical device recall letter to customers in the united states beginning on 18 december 2015. the letter identified affected product, stated the reason for recall and provided instructions for returning unused product to the firm.
tfor details, please refer to the fda websites:
http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event-detail.Cfm?action=detail&id=72867&w=01202016%e2%8c%a9=eng
http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm483792.Htm
http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm483760.Htm
if you are in possession of the affected products, please contact your supplier for necessary actions.
posted on 29 january 2016.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
False low blood glucose results when the confidence levels are above 265 mg / dl, increasing the risk of omission in the diagnosis diabetic decetoacidosis and hyperosmolar hyperglycemic syndrome.
Finnish data is current through April 2018. All of the data comes from Valvira - National Supervisory Authority for Welfare and Health, 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 Finland.
Extra notes in the data
Source: FSCA
Reason
Device failure / feature before use - material / component.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
Extra notes in the data
Action
It was sent in 2016-113. Cessation of the use and withdrawal from the market of certain batches of SPOTCHEM II Glucose, SPOTCHEM II PANEL-1 and SPOTCHEM II PANEL-V, manufactured by ARKRAY Factory, Inc., Japan, because they could provide a lower reading for the element glucose, when the blood glucose exceeds the upper limit of the measurement range.
Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
Extra notes in the data
Reason
The manufacturer reports that he was notified of some cases in which the referenced medical devices do not receive an existing warning or sound alarm, therefore, severe hypoglycemia (low blood sugar level) or severe hyperglycemia (high blood sugar levels) may not be detected. blood), leading to the potential occurrence of adverse events on patients.
Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.