BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 1418527 · Received July 17, 2009

    Report

    Report Number
    MW5012029
    Event Type
    Malfunction
    Date Received
    July 17, 2009
    Report Date
    July 12, 2009
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PRODUCT RECALL QUICK SET PARADIGM LOT 8201928 23 INCH. DATES OF USE: USED LAST 3 YEARS. DIAGNOSIS OR REASON FOR USE: DIABETIC INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK-SET INFUSION SET FPA MEDTRONIC MMT-397 8201028

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR