BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4881637 · Received July 1, 2015

    Report

    Report Number
    1826988-2015-00302
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER FATHER TESTED HIS BLOOD GLUCOSE USING THE CONTOUR NEXT EZ AND THE CONTOUR. HE RECEIVED A 67MG/DL DIFFERENCE BETWEEN READINGS. THE SPECIFIC RESULTS 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. THE TEST STRIPS WERE EXPECTED TO BE RETURNED FOR EVALUATION. REPLACEMENT STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428932 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 4FFEF07

    Patients

    Seq Age Sex Outcome Treatment
    1