BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1900042 · Received November 8, 2010

    Report

    Report Number
    1826988-2010-00762
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS CONTOUR METER. HE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED A RESULT OF 208 MG/DL. THE NORMAL CONTROL RANGE WAS 104-144 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER USED THE LAST OF HIS 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 NBW BAYER HEALTHCARE LLC 9545C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK