BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1935129 · Received December 6, 2010

    Report

    Report Number
    1826988-2010-00823
    Event Type
    Malfunction
    Date Received
    December 6, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 26, 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
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING HIS CONTOUR METER AND RECEIVED A READING OF 254 MG/DL. HE RETESTED USING HIS BREEZE2 METER AND RECEIVED A READING OF 115 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 DECLINED TO TROUBLESHOOT DURING THE CALL. HE ALSO DECLINED TO RETURN HIS CONTOUR TEST STRIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK