BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3090440 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00190
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 7, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HER SON RECEIVED A BLOOD GLUCOSE READING OF OVER 600MG/DL FROM THE CONTOUR NEXT LINK METER, RE-TESTED ON A CONTOUR METER AND ANOTHER METER AND RECEIVED RESULTS OF 293 AND 298MG/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 TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND METER WERE SENT TO THE CUSTOMER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193339 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 2JFED01

    Patients

    Seq Age Sex Outcome Treatment
    1