BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2023788 · Received February 15, 2011

    Report

    Report Number
    1826988-2011-00065
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 2, 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
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED, THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 142 MG/DL FROM HIS CONTOUR METER AND A READING OF 71 MG/DL FROM THE ADVOCATE'S CONTOUR METER. 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 ADVOCATE WAS ADVISED TO RETURN THE TEST STRIPS FOR EVAL. REPLACEMENT 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 0EC3D08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK