BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE

    MDR report key: 1781002 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06562
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    July 18, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE ACTIVE METER PRODUCED A RESULT OF LO WITH NO BLOOD APPLIED TO THE TEST STRIP. NO ACTION TAKEN ON RESULT. 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 70 YR VERAPAMIL - 240MG/DAY| METFORMIN - 2000MG/DAY| ESTROPIPATE - AS NEEDED