BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRASMART

    MDR report key: 576623 · Received February 15, 2005

    Report

    Report Number
    2939301-2005-00752
    Event Type
    Malfunction
    Date Received
    February 15, 2005
    Report Date
    February 11, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "313, 212, 174, AND 286 MG/DL" WITH A LIFESCAN METER, PERFOMED WITHIN 10 MINUTES OF EACH OTHER. THE TEST STRIPS AND CONTROL SOLUTION ARE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 1024820

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR