BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 550970 · Received April 12, 2004

    Report

    Report Number
    2939301-2004-02348
    Event Type
    Malfunction
    Date Received
    April 12, 2004
    Report Date
    April 8, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF 20.9 MMO/ AND 12.1 MMO/L WITH A LIFESCAN METER, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR 20 MG/DL, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF PRECISION. A CONTROL SOLUTION TEST WAS PERFORMED AND THE RESULT FELL WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR