Events

Safety Alert Or Field Safety Notices for Paradigm ambulatory insulin infusion pumps

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Medtronic.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2013/035
  • Date
    2013-05-17
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-paradigm-ambulatory-insulin-infusion-pumps-risk-of-compromised-insulin-therapy
  • Notes / Alerts
    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
    Risk of compromised insulin therapy, which may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). The root causes are:Loose drive support cap (all models)
    Damage to pump if immersed in water (all models)
    Programming issue related to the sensor graph timeout (Paradigm VEO MMT-554 and MMT-754 only).Loose drive support cap:
    Medtronic has received a report of a serious injury related to a loose drive support cap. This may become detached from the pump case, due to impact damage. An attempt to press back the drive support cap may result in an unintended delivery of insulin.
    Water damage:
    This may result in a pump alarm or may cause the buttons to stop working.
    Sensor graph timeout:
    This issue only applies to Paradigm VEO (MMT-554 and MMT-754) pump users who are also using both Medtronic ‘Continuous Glucose Monitoring’ and the ‘Low Glucose Suspend’ feature.Paradigm VEO is equipped with a ’Low Glucose Suspend’ feature, which will automatically suspend insulin delivery when glucose levels are too low, to help reduce the risk of severe hypoglycaemia. Basal insulin delivery may not resume in time if the pump user has the ‘Low Glucose Suspend’ feature enabled and has changed the sensor graph timeout setting to “NONE” from the default setting of two minutes. This could result in hyperglycaemia.
  • Reason
    (medtronic) may lead to severe hypoglycaemia (low blood glucose) or severe hyperglycaemia (high blood glucose). (mda/2013/035).
  • Action
    Identify affected devices. Ensure that all staff and patients receive a copy of Medtronic’s Field Safety Notice (FSN) dated 28 March 2013 and are aware of the recommendations. In particular: Discontinue pump use if drive support cap is loose and contact the manufacturer. Do not immerse the pump in water. Regularly examine the pump for damage, especially after a shock or drop. For Paradigm VEO models, check that the default setting for the sensor graph timeout is not ‘NONE’, if the ‘Low Glucose Suspend’ feature is used.

Device

Paradigm ambulatory insulin infusion pumps
  • Model / Serial
  • Product Description
    Paradigm ambulatory insulin infusion pumps.Manufactured by Medtronic.Models: MMT- 511, 512, 712, 712E, 515, 715, 522, 522K, 722, 722K, 523, 523K, 723, 723K, 554, and 754.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Address
    Lezlie Bridge Regulatory Affairs Manager, UK & Ireland Medtronic Limited Building 9 Croxley Green Business Park Watford WD18 8WW Tel:    01923 212 213 Fax:  01923 225 273Email: lezlie.j.bridge@medtronic.com
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA