BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 660320 · Received January 3, 2006

    Report

    Report Number
    2939301-2006-00048
    Event Type
    Malfunction
    Date Received
    January 3, 2006
    Report Date
    December 27, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF "446, HIGH, 461, 147, 164, 252, 167, 130, 184, 163, 127, AND 244 MG/DL" WITH A LIFESCAN METER, PERFORMED BETWEEN 11-20 MINUTES OF EACH OTHER. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2564133

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR