BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 768332 · Received July 10, 2006

    Report

    Report Number
    1826988-2006-00831
    Event Type
    Malfunction
    Date Received
    July 10, 2006
    Date of Event
    June 26, 2006
    Report Date
    June 26, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THE CUSTOMER'S METER WAS READING LOW. WHILE TROUBLESHOOTING, THE CONTACT PERFORMED NORMAL CONTROL TESTS AND RECEIVED READINGS OF 52, 59, AND 59 MG/DL. THE NORMAL CONTROL RANGE IS 113-162 MG/DL. THE CONTACT DID NOT ALLEGE THE CUSTOMER EXPERIENCED ANY ADVERSE EVENTS. THE STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT STRIPS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODISC 50 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3622A 1A3032AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN