BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 512815 · Received February 17, 2004

    Report

    Report Number
    MW1031166
    Event Type
    Malfunction
    Date Received
    February 17, 2004
    Date of Event
    January 15, 2004
    Report Date
    February 2, 2004
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INSULIN PUMP STARTED IN 2004. PT RECEIVED QUICKSET INFUSION SETS WHEN SHIPPED THE INSULIN PUMP. DURING PROCESS OF ADJUSTING BASAL RATES THEY EXPERIENCED AN EPISODE OF HIGH BLOOD GLUCOSE, RESULTING IN NEED TO CHANGE THEIR INFUSION SET BEFORE 72 HOURS. THE PT CONTINUED TO EXPERIENCE PROBLEMS WITH HYPERGLYCEMIA THAT DID NOT RESPOND TO INSULIN BOLUS, AND NEEDED TO CHANGE THEIR SET. SINCE SET CHANGED THEY HAVE NOT HAD A BLOOD GLUCOSE HIGHER THAN 200 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED QUICKSET INFUSION SET-PLUS FPA MEDTRONIC * 3257799

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other