BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 424695 · Received June 5, 2002

    Report

    Report Number
    2939301-2002-06610
    Event Type
    Malfunction
    Date Received
    June 5, 2002
    Report Date
    May 21, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH ULTRA METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 252, 423, 363 AND 310 MG/DL. TESTS WERE DONE WITHIN 10 MINS. "METER OUT OF SPECIFICATON, PT USING THE SAME FINGER STICK". PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR