BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2033905 · Received March 23, 2011

    Report

    Report Number
    1826988-2011-00154
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALL ENDED BEFORE THE CUSTOMER'S PERSONAL INFO OR PRODUCT INFO COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER WITHOUT THE METER INFO.

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE AND RECEIVED A 100 MG/DL DIFFERENCE BETWEEN READINGS USING HER CONTOUR METER AND ANOTHER METER. DEPENDING ON THE ACTUAL READINGS, THE DIFFERENCE BETWEEN THEM COULD FALL IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS UNABLE TO PROVIDE ANY ADDITIONAL INFO BEFORE ENDING THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK