BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PROFILE

    MDR report key: 392827 · Received May 2, 2002

    Report

    Report Number
    2939301-2002-05876
    Event Type
    Malfunction
    Date Received
    May 2, 2002
    Report Date
    April 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 PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH PROFILE METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 254, 200 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 21%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. CUSTOMER IS CLEANING METER INCORRECTLY AND IS NOT USING CHECK STRIPS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR