BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 868874 · Received March 21, 2007

    Report

    Report Number
    1826988-2007-00144
    Event Type
    Malfunction
    Date Received
    March 21, 2007
    Date of Event
    March 8, 2007
    Report Date
    March 8, 2007
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 262 AND 264 MG/DL. THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVAL. THE CUSTOMER WILL UPGRADE TO A BREEZE 2 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 3622A 1A3358AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR