BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2820975 · Received November 6, 2012

    Report

    Report Number
    1826988-2012-00584
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 12, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER SON RECEIVED A BLOOD GLUCOSE READING OF 50MG/DL FROM HIS CONTOUR AND A READING OF 120 MG/DL FROM ANOTHER METER. 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. CUSTOMER HAS NO STRIPS LEFT SO INFORMATION COULD NOT BE PROVIDED. REPLACEMENT METER WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC 9679

    Patients

    Seq Age Sex Outcome Treatment
    1