BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR NEXT

    MDR report key: 5034195 · Received August 27, 2015

    Report

    Report Number
    1826988-2015-00410
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 6, 2015
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K111268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING ON THE CONTOUR NEXT EZ THAT WAS APPROXIMATELY 20-30MG/DL HIGHER THAN ON THE HOSPITAL METER. THE SPECIFIC READINGS WERE NOT PROVIDED. DEPENDING ON THE ACTUAL READINGS, THE DIFFERENCE BETWEEN THEM COULD FALL 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
    570247 CONTOUR NEXT BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7312 4GFEF08

    Patients

    Seq Age Sex Outcome Treatment
    1