BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4790243 · Received May 22, 2015

    Report

    Report Number
    1826988-2015-00237
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 1, 2015
    Report Date
    May 5, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO CONTROL TESTS WERE RUN ON THE CONTOUR NEXT EZ. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, WHICH WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER RETURNED THE TEST STRIPS FOR EVALUATION. NEW METER, STRIPS AND CONTROL WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334307 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7308 4LFEF03

    Patients

    Seq Age Sex Outcome Treatment
    1