BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1884684 · Received October 25, 2010

    Report

    Report Number
    1826988-2010-00724
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K060470
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S CONTOUR METER. SHE ALLEGED THE CUSTOMER PERFORMED CONTROL TESTS AND REC'D A RESULT OF 587 MG/DL. SHE PERFORMED 2 MORE CONTROL TESTS DURING THE CALL AND REC'D RESULTS OF 518 AND 391 MG/DL. THE NORMAL CONTROL RANGE WAS 107-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE DECLINED TO RETURN THE TEST STRIPS FOR EVAL AND ENDED THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC 7151A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK