BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHECK COMFORT CURVE

    MDR report key: 904125 · Received August 24, 2007

    Report

    Report Number
    MW5003548
    Event Type
    Malfunction
    Date Received
    August 24, 2007
    Report Date
    August 24, 2007
    Manufacturer
    ROCHE
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    ACCUCHECK COMFORT CURVE BLOOD GLUCOSE STRIPS CAT NO 2030365, LOT 549788. THESE STRIPS GAVE READING OF 500 ON THREE DIFFERENT MACHINES. THESE WERE RE-TESTED WITH A DIFFERENT LOT NUMBERED STRIPS WHICH REPORTED NORMAL VALUES. VERBALLY REPORTED FROM PT TO STAFF MEMBER. DATES OF USE: ONE DAY IN 2007. DIAGNOSIS OR REASON FOR USE: DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHECK COMFORT CURVE GLUCOSE TEST STRIPS NBW ROCHE 549788

    Patients

    Seq Age Sex Outcome Treatment
    1 YR