BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 888258 · Received July 31, 2007

    Report

    Report Number
    1826988-2007-00381
    Event Type
    Malfunction
    Date Received
    July 31, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 17, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THAT SHE PERFORMED A CONTROL TEST USING THE CUSTOMER'S METER AND RECEIVED A RESULT OF "LO". WHILE TROUBLESHOOTING, SHE PERFORMED MORE CONTROL TESTS AND RECEIVED A RESULT OF 321 MG/DL. THE NORMAL CONTROL RANGE WAS 110-157 MG/DL. THE CONTACT DID NOT ALLEGE THE CUSTOMER EXPERIENCED ANY ADVERSE EVENTS. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. THE CUSTOMER WAS SENT A BREEZE 2 METER KIT.

    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 1A3390AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR