BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2094017 · Received April 20, 2011

    Report

    Report Number
    1826988-2011-00195
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 18, 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 RECEIVED A BLOOD GLUCOSE READING OF 307 MG/DL FROM HIS CONTOUR METER AND A READING OF 107 MG/DL FROM ANOTHER METER. 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. CUSTOMER SERVICE WAS ATTEMPTING TO GATHER MORE INFO AND TROUBLESHOOT THE SYSTEM, BUT THE CUSTOMER ENDED 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