BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1573660 · Received December 18, 2009

    Report

    Report Number
    1826988-2009-01116
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Date of Event
    December 15, 2009
    Report Date
    December 15, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S CONTOUR METER. SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 217 MG/L. THE NORMAL CONTROL RANGE WAS 110-151 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE ADVOCATE USED THE LAST OF THE TEST STRIPS WHILE TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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