BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 4903025 · Received July 9, 2015

    Report

    Report Number
    1826988-2015-00320
    Event Type
    Malfunction
    Date Received
    July 9, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K121190
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A CONTROL READING THAT WAS NOT MARKED BY THE CONTOUR NEXT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ASKED TO RETURN THE TEST STRIPS FOR INVESTIGATION. NEW METER, STRIPS AND CONTROL WERE SENT TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444765 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7313 4MFEC55

    Patients

    Seq Age Sex Outcome Treatment
    1