BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE TEST STRIPS (50)

    MDR report key: 1163638 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-00999
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER ELITE METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 28 MG/DL. THE NORMAL CONTROL RANGE WAS 73-106 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. A NEW CONTOUR METER KIT WAS SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3918A 7G05DR

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK