BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4910110 · Received July 13, 2015

    Report

    Report Number
    1826988-2015-00332
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 18, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ADVOCATE FROM (B)(6) STATED HER SON RAN A BLOOD TEST ON THE CONTOUR NEXT LINK METER AND THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY.NO ADVERSE EVENT WAS ALLEGED.ADVOCATE WAS ADVISED TO RETURN THE STRIPS FOR EVALUATION. NEW METER AND STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452563 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7322 4LFEF13

    Patients

    Seq Age Sex Outcome Treatment
    1