BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 410568 · Received August 8, 2002

    Report

    Report Number
    2939301-2002-08672
    Event Type
    Malfunction
    Date Received
    August 8, 2002
    Report Date
    August 6, 2002
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 124, 181 MG/DL AND 123, 171 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES (FIRST SET) AND 11-20 MINUTES WITH A DIFFERENCE OF 33% (FIRST SET) AND 29% (SECOND SET). PATIENT DID NOT EXPERIENCE ANY AVERSE EVENTS. 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 62 YR