BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3811997 · Received May 15, 2014

    Report

    Report Number
    1826988-2014-00169
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ADDRESS AND PHONE WERE NOT PROVIDED.

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER BROTHER RECEIVED A BLOOD GLUCOSE READING OF 190MG/DL ON THE CONTOUR NEXT LINK , WAS RETESTED ON A HOSPITAL METER AND THE READING WAS 55MG/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
    292105 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 2HFEC02

    Patients

    Seq Age Sex Outcome Treatment
    1