BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 100 TEST STRIPS

    MDR report key: 809089 · Received October 9, 2006

    Report

    Report Number
    1826988-2006-01269
    Event Type
    Malfunction
    Date Received
    October 9, 2006
    Date of Event
    September 26, 2006
    Report Date
    September 26, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THE CUSTOMER'S METER READ "HI." WHILE TROUBLESHOOTING, THE CUSTOMER RECEIVED 2 CONTROL TEST READINGS OF 356 MG/DL. THE NORMAL CONTROL RANGE IS 121-174 MG/DL. THE CONTACT DID NOT ALLEGE THE CUSTOMER EXPERIENCED ANY ADVERSE EVENTS. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT PRODUCTS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTODISC 100 TEST STRIPS BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 3627A 1A3160AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR