BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHECK ADVANTAGE

    MDR report key: 35181 · Received August 12, 1996

    Report

    Report Number
    MW1009693
    Event Type
    Malfunction
    Date Received
    August 12, 1996
    Date of Event
    July 24, 1996
    Report Date
    July 30, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DIFFERENT READINGS RESULTING FROM EITHER NOT ENOUGH BLOOD SAMPLE FOR MACHINE TO FUNCTION PROPERLY OR MACHINE IS NOT RECORDING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHECK ADVANTAGE BLOOD GLUCOSE METER CFR BOEHRINGER MANNHEIM CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR