BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1424638 · Received March 31, 2009

    Report

    Report Number
    1826988-2009-00278
    Event Type
    Malfunction
    Date Received
    March 31, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 3, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 337 MG/DL. THE NORMAL CONTROL RANGE WAS 103-142 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080G 8EC3C08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK