BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3840372 · Received May 30, 2014

    Report

    Report Number
    1826988-2014-00189
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 262MG/DL ON THE CONTOUR NEXT EZ METER, AND A READING OF 104MG/DL FROM THE HOSPITAL LAB.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
    318626 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7308 3MFEC03

    Patients

    Seq Age Sex Outcome Treatment
    1