BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS TEST STRIPS

    MDR report key: 1754629 · Received July 8, 2010

    Report

    Report Number
    1826988-2010-00439
    Event Type
    Malfunction
    Date Received
    July 8, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 23, 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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 414 MG/DL. THE NORMAL CONTROL RANGE WAS 100-137 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER USED THE LAST STRIP OF THE BOTTLE. NO PRODUCT TO RETURN. NO PRODUCT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TS TEST STRIPS NBW BAYER HEALTHCARE, LLC 1820 9LD3E03A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK