BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1821579 · Received August 27, 2010

    Report

    Report Number
    1826988-2010-00578
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 17, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 219 MG/DL FROM HIS CONTOUR METER AND READINGS OF 87 MG/DL FROM 2 OTHER METERS. 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 EVALUATION. 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 7080G 9GC3C05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK