BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS STRIPS

    MDR report key: 1754652 · Received July 8, 2010

    Report

    Report Number
    1826988-2010-00431
    Event Type
    Malfunction
    Date Received
    July 8, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 18, 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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 400 AND 400 MG/DL. THE NORMAL CONTROL RANGE WAS 100-137 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CONTROL SOLUTION WAS SENT FOR FURTHER TROUBLESHOOTING. NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVAL AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS STRIPS NBW BAYER HEALTHCARE, LLC 1820 9GD3E04B

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK