BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1760880 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06031
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K930979
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED MISSING SEGMENTS IN THE RESULT DISPLAY ON THE ADVANTAGE SYSTEM. REPORTER ALLEGED NO ACTIONS OR TREATMENT BASED ON RESULTS. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT 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 85 YR GLYBURIDE - 3 YEARS - 5MG TWICE DAILY| METFORMIN - 3 YEARS - 1000MG TWICE DAILY