BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1884661 · Received October 25, 2010

    Report

    Report Number
    1826988-2010-00719
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    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 CUSTOMER CALLED FOR HELP WITH HER CONTOUR USB METER. SHE ALLEGED HER GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. WHILE TROUBLESHOOTING, THE CUSTOMER PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 226 MG/DL. THE NORMAL CONTROL RANGE WAS 108-150 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE, LLC 7070A 9KC3B32

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK