BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2272359 · Received August 26, 2011

    Report

    Report Number
    1826988-2011-00480
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 27, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE STATED THE CUSTOMER WAS RECEIVING HIGHER BLOOD GLUCOSE READINGS FROM HIS CONTOUR METER. THE CUSTOMER ALSO PERFORMED COMPARISON TESTS USING ANOTHER METER. THE ADVOCATE STATED THE CUSTOMER REC'D READINGS OF 313, 131, 148, 185 AND 150 MG/DL. IT WAS NOT CLEAR WHICH READINGS CAME FROM WHICH METER. THE DIFFERENCE BETWEEN THE HIGH READING OF 313 MG/DL AND READINGS OF 131, 148 AND 150 MG/DL FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE ADVOCATE DECIDED TO END THE CALL. ATTEMPTS TO CONTACT THE CUSTOMER AFTER THE INITIAL CALL WERE NOT SUCCESSFUL. NO PRODUCT WILL BE RETURNED.

    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