BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 4251605 · Received November 14, 2014

    Report

    Report Number
    1826988-2014-00407
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 21, 2014
    Report Date
    October 21, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED STATING HE WAS GETTING HIGH BLOOD GLUCOSE READINGS ON THE CONTOUR. HE RAN A BLOOD TEST ON ONE CONTOUR METER AND THE READING WAS 138MG/DL. DURING THE CALL HE RETESTED ON ANOTHER CONTOUR METER AND THE READING WAS 78MG/DL. THE DIFFERENCES BETWEEN READINGS FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737192 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7098C 3MJ3B01

    Patients

    Seq Age Sex Outcome Treatment
    1