BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE TEST STRIPS (50)

    MDR report key: 1012926 · Received March 11, 2008

    Report

    Report Number
    1826988-2008-00275
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 16, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 170 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. REPLACEMENT TEST STRIPS WERE 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 NOT PROVIDED 6L05ES

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK