BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 846478 · Received May 8, 2007

    Report

    Report Number
    1826988-2007-00241
    Event Type
    Malfunction
    Date Received
    May 8, 2007
    Date of Event
    April 24, 2007
    Report Date
    April 24, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP IN RUNNING A CONTROL TEST. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND REC'D RESULTS OF 258 AND 271 MG/DL. THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL. THE CUSTOMER WAS SENT A REPLACEMENT BREEZE2 METER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODISC 50 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3627AC 1A3248AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR