BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 657507 · Received December 21, 2005

    Report

    Report Number
    2939301-2005-04693
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Report Date
    October 13, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE LAY PT CONTACTED LIFESCAN ALLEGING HIS ONE TOUCH ULTRA METER WAS READING INACCURATELY ERRATIC. THE PT OBTAINED RESULTS OF 220, 156, 145, AND 168 MG/DL IN BACK-TO-BACK TESTING ON THE REPORTED METER; THE RESULTS WERE NOT PRECISE. THE PT RECEIVED NO MEDICAL ATTENTION. THE CUSTOMER CARE REP (CCR) WALKED THE PT THROUGH TWO CONTROL SOLUTION TESTS; ONE TEST FELL OUTSIDE OF SPECS AND THE PT WAS UNABLE/UNWILLING TO ANSWER WHETHER THE OTHER PASSED OR FAILED. THE 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 2584634

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR