BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 575694 · Received February 10, 2005

    Report

    Report Number
    2939301-2005-00674
    Event Type
    Malfunction
    Date Received
    February 10, 2005
    Report Date
    February 7, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "97, 162, 144, AND 172 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE CUSTOMER CARE REPRESENTATIVE WALKED THE PATIENT THROUGH TWO BLOOD GLUCOSE TESTS WITH A NEW VIAL OF TEST STRIPS AND OBTAINED RESULTS OF 144 MG/DL AND 150 MG/DL. THE TEST STRIPS ARE BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2535832

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN