Events

Field Safety Notices about Paradigm Insulin Infusion Pump

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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
    Field Safety Notice
  • Event Number
    SN2014(20)
  • Date
    2014-04-24
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/paradigm-insulin-infusion-pump.-priority-2-warning&id=ffcff925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "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
    Medtronic has received a number of reports regarding users who have accidentally programmed the pump to deliver the maximum bolus amount, including one incident that resulted in severe hypoglycaemia.  all insulin delivery programmed through the main menu will allow the down arrow button to scroll from 0.0 units to the programmed maximum bolus insulin dose.
  • Action
    The IMB advise that users:  (1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached.  (2) When programming insulin doses through the Main Menu, pay close attention because scrolling down allows the dose displayed on the screen to go from 0.0 units to the maximum programmed insulin dose.  (3) Always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery.  (4) The Max Bolus and Max Basal safety limits should be programmed in your patients’ pumps according to their individual insulin needs.  (5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Device

Paradigm Insulin Infusion Pump
  • Model / Serial
  • Product Description
    Paradigm Insulin Infusion Pump
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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
    HPRA