BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 4102839 · Received September 19, 2014

    Report

    Report Number
    1826988-2014-00319
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 27, 2014
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALL ENDED BEFORE THE CUSTOMER'S PERSONAL INFORMATION OR PRODUCT INFORMATION COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE WITHOUT THE PRODUCT INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 140MG/DL ON THE CONTOUR METER, RE-TESTED ON A DIFFERENT METER AND THE READING WAS 63MG/DL. 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. THE CUSTOMER ENDED THE CALL BEFORE ADDITIONAL INFORMATION COULD BE OBTAINED. PRODUCT WAS NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584047 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1