BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1749165 · Received May 27, 2010

    Report

    Report Number
    1826988-2010-00360
    Event Type
    Malfunction
    Date Received
    May 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    May 21, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO METER INFO WAS PROVIDED, SO IT WAS NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE OR A 510K NUMBER. THE COMPLAINT INFO WAS RECEIVED FROM THE FDA. THE REPORT NUMBER IS (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN'S OFFICE REPORTED THAT COMPARISON TESTS WERE PERFORMED USING CONTOUR AND A COMPETITOR'S METER. THE CONTOUR READ IN THE 101-108 MG/DL RANGE, WHILE THE OTHER METER READ IN THE 200 MG/DL RANGE. DEPENDING ON THE READINGS OF THE COMPETITOR'S METER, THE DIFFERENCE COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. NO OTHER INFO WAS PROVIDED ABOUT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK