BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3800562 · Received May 8, 2014

    Report

    Report Number
    1826988-2014-00155
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 12, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED BLOOD GLUCOSE READINGS OF 447, 415, 409MG/DL ON THE CONTOUR NEXT EZ METER, RE-TESTED ON A DIFFERENT METER AND THE READING WAS172MG/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 THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279307 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 3JFEF03

    Patients

    Seq Age Sex Outcome Treatment
    1