BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1771124 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01226
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 15, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED BLOOD GLUCOSE RESULT OF 601 MG/DL ON THE ADVANTAGE SYSTEM. THE RESULT IS OUTSIDE THE NUMERIC RANGE OF 10-600 MG/DL OF THE DEVICE. 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 BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEDICAL PRODUCTS UNK