BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA SMART

    MDR report key: 656936 · Received December 22, 2005

    Report

    Report Number
    2939301-2005-05889
    Event Type
    Malfunction
    Date Received
    December 22, 2005
    Report Date
    December 16, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF "5.5 MMO/L" WITH A LIFESCAN METER AND "3.8 MMO/L" ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINS OF EACH OTHER. BETWEEN THE TESTS THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF ACCURACY. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA SMART GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2542107

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR