BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1821597 · Received August 27, 2010

    Report

    Report Number
    1826988-2010-00584
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 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
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. SHE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED A RESULT OF 355 MG/DL. THE NORMAL CONTROL RANGE WAS 109-151 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS AND A NEW METER WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC NOT PROVIDED 8JC3D07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK