BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1600690 · Received February 1, 2010

    Report

    Report Number
    1826988-2010-00049
    Event Type
    Malfunction
    Date Received
    February 1, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 19, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HE CONTOUR METER. SHE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED RESULTS OF 25 AND 19 MG/DL. THE NORMAL CONTROL RANGE WAS 111-154 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 (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7098C 9FC3D12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK