BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHECK ADVANTAGE

    MDR report key: 33908 · Received July 5, 1996

    Report

    Report Number
    MW1009439
    Event Type
    Malfunction
    Date Received
    July 5, 1996
    Date of Event
    June 19, 1996
    Report Date
    June 26, 1996
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADEQUATE AMOUNT OF BLOOD PLACED IN MACHINE. BLOOD SUGAR READ AT 29. NURSE ASKED PT IF HE FELT LIKE HIS BLOOD SUGAR WAS 29. PT STATED "NO." ANOTHER ADEQUATE DROP OF BLOOD PLACED IN NEW STRIP. BLOOD SUGAR READ 140. MACHINE WAS QUALITY CONTROL CHECKED 6/19/96, 0800.

    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 75 YR