BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 5086693 · Received September 18, 2015

    Report

    Report Number
    1826988-2015-00457
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 27, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 251MG/DL ON THE CONTOUR NEXT LINK, WAS RE-TESTED ON A HOSPITAL METER AND THE READING WAS 120MG/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. PRODUCT WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620359 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7312 4EFEF12

    Patients

    Seq Age Sex Outcome Treatment
    1