BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1568248 · Received December 11, 2009

    Report

    Report Number
    1826988-2009-01054
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 27, 2009
    Report Date
    November 27, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 317 MG/DL. THE NORMAL CONTROL RANGE WAS 110-151 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE USED THE LAST OF THE CUSTOMER'S TEST STRIPS WHILE TROUBLESHOOTING, SO NO PRODUCT WILL BE RETURNED. A REPLACEMENT METER WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK