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/2014/019
  • Date
    2014-05-29
  • 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-hypoglycaemia
  • 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 hypoglycaemia due to incorrect selection and delivery of bolus amount.Medtronic has received reports of users accidentally programming the pump to deliver the maximum bolus amount.
  • Reason
    (medtronic) risk due to incorrect selection and delivery of bolus amount. (mda/2014/019).
  • Action
    Identify affected pumps.Ensure that all staff and patients receive the relevant copy of Medtronic’s Field Safety Notice (FSN) dated March 2014 and follow the recommendations.In particular:When programming insulin doses through the ‘Main Menu’, be aware that scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose. Always confirm that the insulin dose flashing on the display screen is correct before starting delivery. Make sure the ‘Max Bolus’ and ‘Max Basal’ settings are programmed according to individual insulin needs as determined by the healthcare professional.

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