BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTODISC 100 TEST STRIPS

    MDR report key: 863108 · Received September 15, 2006

    Report

    Report Number
    1826988-2006-01203
    Event Type
    Malfunction
    Date Received
    September 15, 2006
    Date of Event
    September 6, 2006
    Report Date
    September 6, 2006
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HER METER. WHILE TROUBLESHOOTING, SHE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 40 MG/DL. THE NORMAL CONTROL RANGE IS 113-163 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE TEST STRIPS ARE TO BE RETURNED FOR EVAL 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 3627AS BA3161AA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR