BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 5006637 · Received August 17, 2015

    Report

    Report Number
    1826988-2015-00398
    Event Type
    Malfunction
    Date Received
    August 17, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 24, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HIS WIFE'S BLOOD GLUCOSE READINGS ON THE CONTOUR WOULD SOMETIMES BE 20-40MG/DL DIFFERENT THAN READINGS FROM THE DOCTOR'S METER. SPECIFIC READINGS WERE NOT PROVIDED. DEPENDING ON THE ACTUAL READINGS, THE DIFFERENCE BETWEEN THEM COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT NO ADVERSE EVENT WAS ALLEGED. NEW METER WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543489 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 4CJ3D03

    Patients

    Seq Age Sex Outcome Treatment
    1