BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2063076 · Received April 11, 2011

    Report

    Report Number
    1826988-2011-00174
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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 290 MG/DL. THE NORMAL CONTROL RANGE WAS 106-146 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE 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 7080G 0AC3C05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK