BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH II

    MDR report key: 421202 · Received October 4, 2002

    Report

    Report Number
    2939301-2002-10017
    Event Type
    Malfunction
    Date Received
    October 4, 2002
    Report Date
    September 23, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH II METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE "403 MG/DL AND "525 MG/DL" ON THEIR METER. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 23%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. TWO CONTROL SOLUTION TEST PASSED IN 2002 (RESULT: 132, 130 - RANGE: 102-134). NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR