BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2222340 · Received July 15, 2011

    Report

    Report Number
    1826988-2011-00423
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND RECEIVED A READING OF 50 MG/DL, WHILE ANOTHER METER READ 170 MG/DL. ON ANOTHER OCCASION, THE CONTOUR READ "LO", WHILE THE OTHER METER READ 226 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER WAS ADVISED TO RETURN THE TEST STRIPS FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098C 1DC3A06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK