BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 50 TEST STRIPS

    MDR report key: 810023 · Received January 11, 2007

    Report

    Report Number
    1826988-2007-00002
    Event Type
    Malfunction
    Date Received
    January 11, 2007
    Date of Event
    December 11, 2006
    Report Date
    December 11, 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
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED READINGS OF 368 AND 366 MG/DL. THE NORMAL CONTROL RANGE WAS 110-159 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT TEST 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 IA3235AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR