BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ADVANTAGE

    MDR report key: 1761130 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06308
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    May 15, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K032552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS SEEING WISPS OF SMOKE COMING OFF OF THE ADVANTAGE SYSTEM; SHE DOES NOT RECALL IF THE METER FELT WARM TO THE TOUCH OR NOT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER, METER WAS DISCARDED; 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 52 YR GLIPIZIDE XL - 5MG ,ONCE DAILY, 5 YEARS| ZOLOFT - 200MG, ONCE DAILY, 4 YEARS| METFORMIN - 500MG, 2TABS 2/DAY, 5 YEARS| SOMA - 350MG, AS NEEDED| AMBIEN - 10MG, AS NEEDED| LORTAB - 10MG, AS NEEDED| XANAX - 0.5MG, AS NEEDED| BENADRYL - 50MG, AS NEEDED| IBUPROFEN - 800MG, AS NEEDED| ZOCOR - 40MG, ONCE DAILY, 2 YEARS