BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4251720 · Received November 14, 2014

    Report

    Report Number
    1826988-2014-00415
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 27, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A HIGH OUT OF RANGE CONTROL RESULT OF 271MG/DL ON THE CONTOUR NEXT USB. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER¿S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE TEST STRIPS ARE EXPECTED TO BE RETURNED FOR EVALUATION. NEW STRIPS, METER AND CONTROL WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737378 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7308 4FFEC06

    Patients

    Seq Age Sex Outcome Treatment
    1