BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 390639 · Received April 23, 2002

    Report

    Report Number
    2939301-2002-05585
    Event Type
    Malfunction
    Date Received
    April 23, 2002
    Report Date
    April 18, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH ULTRA METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 240, 185, 195 AND 155 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES. PATIENT WAS USING THE SAME FINGER STICK. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. NO FURTHER INFORMATION 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 73 YR