BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONT TOUCH ULTRA

    MDR report key: 386889 · Received April 2, 2002

    Report

    Report Number
    2939301-2002-04757
    Event Type
    Malfunction
    Date Received
    April 2, 2002
    Report Date
    March 27, 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 EXPERIENING INACCURATE ERRATIC RESULTS WITH A OTU METER. THE PT'S BLOOD GLUCOSE RESULTS WERE 160MG/DL, 129MG/DL, 112MG/DL. TESTS WERE DONE WITHIN 2 MINUTES WITH A DIFFERENCE OF 21%. PT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFO HAS BEEN REPORTED. NOTE - IN THE POTENTIAL MEDICAL IT MENTIONS THAT THEY ARE UNSURE OF THE EXACT RESULTS AND ABOUT USING DIFFERENT FINGERS FOR ALL THREE TESTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR