BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3811969 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00166
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 304MG/DL ON THE CONTOUR NEXT LINK METER. HE TESTED HIS BLOOD ON A DIFFERENT METER AND IT INDICATED THE READING WAS OUTSIDE OF THE METER'S READOUT RANGE ON THE HIGH END. DEPENDING ON THE SPECIFIC READING, THE DIFFERENCE BETWEEN THE TWO COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCES CLINICALLY SIGNIFICANT NO ADVERSE EVENT WAS ALLEGED. A NEW METER AND SAMPLE STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290175 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 3JFEF08

    Patients

    Seq Age Sex Outcome Treatment
    1