BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 100 TEST STRIPS

    MDR report key: 772222 · Received August 7, 2006

    Report

    Report Number
    1826988-2006-01016
    Event Type
    Malfunction
    Date Received
    August 7, 2006
    Date of Event
    July 24, 2006
    Report Date
    July 24, 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 CUSTOMER STATED THAT HE PERFORMED 2 CONTROL TESTS AND RECEIVED RESULTS OF 29 AND 59 MG/DL. THE NORMAL CONTROL RANGE IS 113-162 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT STRIPS 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 1A3076AA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN