BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 704215 · Received November 14, 2005

    Report

    Report Number
    2939301-2005-04961
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Report Date
    November 2, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED BLOOD GLUCOSE RESULTS OF "90 MG/DL" WITH THE LIFESCAN METER AND "129 MG/DL" ON A LAB DEVICE, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. THE PT ALSO REPORTED BLOOD GLUCOSE RESULTS OF "140 MG/DL" WITH THE LIFESCAN METER AND "200 MG/DL" ON A LAB DEVICE, PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 242580A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN