BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2231288 · Received July 25, 2011

    Report

    Report Number
    1826988-2011-00427
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 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
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S CONTOUR METER. SHE PERFORMED CONTROL TESTS DURING THE CALL AND RECEIVED A RESULT OF 221 MG/DL. THE NORMAL CONTROL RANGE WAS 108-149 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS 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 0LC3C09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK