BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 1128543 · Received August 15, 2008

    Report

    Report Number
    1826988-2008-00873
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALSO RETURNED AUTODISC TEST STRIPS WITH PRODUCT CODE OF 3622A AND LOT NUMBER AT3608AA. THE MANUFACTURE DATE WAS 01/2008. EXPIRATION DATE 07/2009.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER BREEZE2 METER. SHE PERFORMED CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED A RESULT OF 209 MG/DL. THE NORMAL CONTROL RANGE WAS 113-163 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    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 1T3499AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK