BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1689358 · Received May 7, 2010

    Report

    Report Number
    1826988-2010-00318
    Event Type
    Malfunction
    Date Received
    May 7, 2010
    Date of Event
    April 27, 2010
    Report Date
    April 27, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER CONTOUR METER. SHE ALLEGED THAT SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 350 MG/DL. THE NORMAL CONTROL RANGE WAS 111-154 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE 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 (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7097C 9FC3D12

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK