BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 419492 · Received September 24, 2002

    Report

    Report Number
    2939301-2002-09809
    Event Type
    Malfunction
    Date Received
    September 24, 2002
    Report Date
    September 20, 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

    CUSTOMER REPORTED EXPERIENCING INACCURATE ERRATIC RESULTS WITH A OT BASIC ENHANCED METER. BLOOD GLUCOSE RESULTS WERE 188, 248, 160, 139, AND 277 MG/DL. TESTS WERE DONE WITHIN 10 MINUTES WITH A DIFFERENCE OF 29%. THEY DID EXPERIENCE HIGH BLOOD SUGAR SYMPTOMS PRIOR TO DOING THE BACK TO BACK COMPARISON, WHICH THEY WERE TREATED FOR IN THE HOSP ALONG WITH OTHER HEALTH CONDITIONS. THE CUSTOMER CHOSE NOT TO DISCLOSE THE OTHER HEALTH CONDITIONS.

    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 48 YR