BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 394469 · Received May 8, 2002

    Report

    Report Number
    2939301-2002-06105
    Event Type
    Malfunction
    Date Received
    May 8, 2002
    Report Date
    May 3, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A ONE TOUCH BASIC ENHANCED METER. THE PATIENT'S BLOOD GLUCOSE RESULTS WERE 141, 193 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 28%. PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS. CUSTOMER IS USING EXPIRED CONTROL SOLUTION FOR TESTS. NO FURTHER INFORMATION HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR