BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3800610 · Received May 8, 2014

    Report

    Report Number
    1826988-2014-00159
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED A SECOND LOT# OF CONTOUR NEXT TEST STRIPS FOR EVALUATION, WHICH WAS NOT INITIALLY PROVIDED. LOT# 3FFEF02, EXPIRATION DATE 06/30/2015. MANUFACTURE DATE 06/01/2013. THE EVALUATION RESULTS FOR THIS LOT#: USING CUSTOMER'S CONTROL SOLUTION, THE READINGS WERE AN AVERAGE OF 3MG/DL HIGH OUT OF SPEC. THE RETENTION REAGENT GAVE SATISFACTORY PERFORMANCE.

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER SON RECEIVED A BLOOD GLUCOSE READING OF 199MG/DL FROM THE CONTOUR NEXT LINK METER, RE-TESTED ON A DIFFERENT METER AND RECEIVED 54MG/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 ALLEGEDTHE TEST STRIPS WERE RETURNED FOR EVALUATION.REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279386 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 3HFEC03

    Patients

    Seq Age Sex Outcome Treatment
    1