BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1771157 · Received February 5, 2008

    Report

    Report Number
    1823260-2008-01235
    Event Type
    Malfunction
    Date Received
    February 5, 2008
    Date of Event
    January 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED BLOOD GLUCOSE RESULT OF 650 MG/DL ON THE ACTIVE S SYSTEM TWICE IN ONE DAY. 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 ACTIVE BLOOD GLUCOSE MONITORING DEVICE - NBW NBW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR METFORMIN, 1000 MG TWICE DAILY - 1 WEEK| FUROSEMIDE, 40 MG 1/DAY - 6 YEARS| NOVOLOG, 30 UNITS - 3 YEARS| SULAR, 20 MG 1/DAY - 6-7 YEARS| "PACEROND", 200 MG 1/DAY - 3 YEARS| METOPROLOL, 25 MG 1/DAY - 3 YEARS| VYTORIN, 25 MG 1/DAY - 4 YEARS| WARFARIN, 6 MG 1/DAY - 5 YEARS