BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN PUMP INFUSION

    MDR report key: 8883600 · Received August 9, 2019

    Report

    Report Number
    MW5088953
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    August 4, 2019
    Report Date
    August 7, 2019
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC GLUCOSE PUMP INFUSION SET HAS AN ISSUE WHERE ONE OF THE ARMS ON THE CAP OF THE INFUSION SET THAT LOCKS IT INTO THE PUMP BREAKS AND INSULIN NO LONGER DOSES CORRECTLY FROM PUMP CAUSING HIGH BLOOD GLUCOSE. THERE IS NO ALARM FROM THE INSULIN PUMP WHEN THIS OCCURS SO THE USER CAN BE UNAWARE THIS IS THE CAUSE OF HIGH EGS FOR A FEW DAYS TIME. MEDTRONIC WAS MADE AWARE BUT HAS TAKEN NO FURTHER ACTION AS OF YET. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672004 INSULIN PUMP INFUSION SET, ADMINISTRATION, INTRAVASCULAR FPA MEDTRONIC MINIMED SILHOUETTE PARADIGM 5256434

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR