BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2222378 · Received July 15, 2011

    Report

    Report Number
    1826988-2011-00425
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR USB METER AND RECEIVED A READING OF 122 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 55 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 CUSTOMER WAS ADVISED TO RETURN HIS TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER. THE METER WAS ALSO REPLACED AT THE CUSTOMER'S INSISTENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080G 0JC3A09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK