BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TS TEST STRIPS

    MDR report key: 1786442 · Received July 27, 2010

    Report

    Report Number
    1826988-2010-00492
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 18, 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
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER PERFORMED CONTROL TESTS ON HER CONTOUR TS METER AND RECEIVED RESULTS OF 308 AND 208 MG/DL. THE NORMAL CONTROL RANGE WAS 100-137 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. 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 TS TEST STRIPS NBW BAYER HEALTHCARE, LLC 1820 9LD3E03A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK