BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 3090427 · Received May 2, 2013

    Report

    Report Number
    1826988-2013-00186
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED HIS SON RECEIVED A BLOOD GLUCOSE READING OF 23MG/DL FROM THE CONTOUR NEXT LINK METER, RE-TESTED ON A DIFFERENT METER AND RECEIVED 151MG/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 METER WAS REPLACED AT THE REQUEST OF THE ADVOCATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191989 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7311 2KFEC04

    Patients

    Seq Age Sex Outcome Treatment
    1