BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 1413892 · Received July 9, 2009

    Report

    Report Number
    MW5011899
    Event Type
    Malfunction
    Date Received
    July 9, 2009
    Report Date
    July 9, 2009
    Manufacturer
    MEDTRONIC MINI MED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: DIABETES TYPE 1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM QUICK SET FPA MEDTRONIC MINI MED 8200812
    2 MEDTRONIC MINIMED PARADIGM QUICK SET FPA MEDTRONIC MINI MED 8200815

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR