BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2990014 · Received March 5, 2013

    Report

    Report Number
    1826988-2013-00084
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    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

    Description of Event or Problem · 1

    AN ADVOCATE FROM CANADA STATED HIS DAUGHTER RECEIVED A BLOOD GLUCOSE READING OF 0.6MMOL/L ON THE CONTOUR LINK, RE-TESTED WITH THE CONTOUR AND RECEIVED 8.7MMOL/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 TEST STRIPS ARE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93813 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 2HC3A03

    Patients

    Seq Age Sex Outcome Treatment
    1