BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2223163 · Received August 16, 2011

    Report

    Report Number
    1826988-2011-00474
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 329 MG/DL. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 157 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 WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080G 0JC3D01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK