BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 584616 · Received March 11, 2005

    Report

    Report Number
    2939301-2005-01152
    Event Type
    Malfunction
    Date Received
    March 11, 2005
    Report Date
    March 10, 2005
    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 BLOOD GLUCOSE RESULTS OF "200, 144, 173, AND 123 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. THE TEST STRIPS AND CONTROL SOLUTION ARE BEING REPLACED TO FURTHER TROUBLESHOOT THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT CFR LIFESCAN, INC. NA 2524008

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN