BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 6017008 · Received October 11, 2016

    Report

    Report Number
    1826988-2016-00367
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 27, 2016
    Report Date
    September 27, 2016
    Manufacturer
    ASCENSIA DIABETES CARE US INC.
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 86MG/DL ON THE DOCTOR'S METER, RETESTED ON THE CONTOUR AND THE READING WAS 196MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670054 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW ASCENSIA DIABETES CARE US INC. 7080G 5EJ3D06

    Patients

    Seq Age Sex Outcome Treatment
    1