BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR LINK

    MDR report key: 2842514 · Received November 21, 2012

    Report

    Report Number
    1826988-2012-00622
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K110587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INFORMATION COULD NOT BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE WITHOUT THE METER INFORMATION.

    Description of Event or Problem · 1

    A (B)(6) ADVOCATE STATED HER SON RAN THREE BLOOD GLUCOSE TESTS AMONG HIS THREE CONTOUR METERS AND THE READINGS WERE HI, 10.1 AND 10.2MMOL/L.THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT.NO ADVERSE EVENTS WERE ALLEGED.THE ADVOCATE DID NOT HAVE THE METER OR STRIPS WITH HER SO THE PRODUCT INFORMATION COULD NOT BE PROVIDED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR LINK BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1