BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1771103 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01202
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 8, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UPON TROUBLESHOOTING WITH THE MANUFACTURER, IT WAS NOTED THAT ICONS WERE DARKENED ON THE ADVANTAGE METER DISPLAY. 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 64 YR SPIRONOLACTONE - 25MG/DAY| ASPIRIN - DAILY| FUROSEMIDE - 40MG/DAY| LISINOPRIL - 20MG/DAY| METFORMIN - 1000MG/DAY| CARBETOTOL - 37.5MG/DAY| SIMVASTATIN - 40MG/DAY