BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2842327 · Received November 21, 2012

    Report

    Report Number
    1826988-2012-00608
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 26, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED A READING OF 300 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 135 MG/DL. 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. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7080G 2CC3F02

    Patients

    Seq Age Sex Outcome Treatment
    1