BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2365060 · Received December 9, 2011

    Report

    Report Number
    1826988-2011-00695
    Event Type
    Malfunction
    Date Received
    December 9, 2011
    Date of Event
    November 12, 2011
    Report Date
    November 12, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    LFR
    PMA / PMN Number
    K062058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR SYSTEM.SHE PERFORMED CONTROL TESTS DURING THE CALL AND RECEIVED A RESULT OF 14 MG/DL.THE NORMAL CONTROL RANGE WAS 102-140 MG/DL.NO ADVERSE EVENTS WERE ALLEGED.THE TEST STRIPS WERE 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 BLOOD GLUCOSE TEST STRIPS LFR BAYER HEALTHCARE LLC 7098C 1GC3A10

    Patients

    Seq Age Sex Outcome Treatment
    1