BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE TEST STRIPS

    MDR report key: 1760877 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06034
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 30, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K982089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THE USE BY DATE ON THE TEST STRIP VIAL FOR THE ADVANTAGE SYSTEM IS 7/28/07; MANUFACTURER'S DATABASE AND BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 11/30/2003. NO QUALITY CONTROLS WERE USED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ADVANTAGE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS NBW ROCHE DIAGNOSTICS 522657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA