BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCHECK ADVANTAGE STRIPS

    MDR report key: 412860 · Received August 27, 2002

    Report

    Report Number
    MW1025971
    Event Type
    Malfunction
    Date Received
    August 27, 2002
    Date of Event
    August 20, 2002
    Report Date
    August 27, 2002
    Manufacturer
    ROCHE
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HIGH READINGS (400-500) WHEN BLOOD SUGAR WAS EITHER NORMAL OR LOW ENOUGH FOR A HYPOGLYCEMIC REACTION. READINGS WERE COMPARED WITH ANOTHER SCT OF STRIPS THAT READ NORMAL (AROUND 100). RPTR IS CONCERNED THAT OTHERS HAVE THIS LOT OF STRIPS AND COULD BE IN DANGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUCHECK ADVANTAGE STRIPS BLOOD GLUCOSE TEST STRIP CFR ROCHE NA 545846

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR