BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 582244 · Received March 3, 2005

    Report

    Report Number
    2939301-2005-01000
    Event Type
    Malfunction
    Date Received
    March 3, 2005
    Report Date
    March 1, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF "173, 153, 123, AND 114 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE CUSTOMER CARE PRESENTATIVE WALKED THE PT THROUGH TWO BLOOD GLUCOSE TESTS AND OBTAINED RESULTS OF 119 MG/DL AND 121 MG/DL. THE METER, TEST STRIPS, AND CONTROL SOLUTION 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 2518480

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR