BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1861310 · Received October 5, 2010

    Report

    Report Number
    1826988-2010-00689
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 25, 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
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 441 MG/DL. THE NORMAL CONTROL RANGE WAS 108-149 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TO PERFORM ADD'L CONTROL TESTS DURING THE CALL AS SHE ONLY HAD A FEW TEST STRIPS LEFT. THE REMAINING 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 7097C 9KC3C14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK