BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRASMART

    MDR report key: 567499 · Received January 14, 2005

    Report

    Report Number
    2939301-2005-00210
    Event Type
    Malfunction
    Date Received
    January 14, 2005
    Report Date
    January 8, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT CONTACTED LIFESCAN ALLEGING THAT THEIR ONE TOUCH ULTRA SMART METER WAS READING INACCURATELY ERRATIC. THEY OBTAINED RESULTS OF 133, 280, AND 320 ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2526967

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN