BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRASMART

    MDR report key: 719277 · Received November 14, 2005

    Report

    Report Number
    2939301-2005-05087
    Event Type
    Malfunction
    Date Received
    November 14, 2005
    Report Date
    October 31, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE LAY PATIENT CONTACTED LIFESCAN ALLEGING THAT HER ONE TOUCH ULTRA SMART METER WAS READING INACCURATELY ERRATIC. THE PATIENT OBTAINED RESULTS OF 99, 138, 152, 143, AND 151 MG/DL ON THE REPORTED METER WITHIN 10 MINUTES OF EACH OTHER. THE PT RECEIVED NO MEDICAL ATTENTION AT THE TIME OF CONCERN. THE CUSTOMER CARE AGENT (CCA) WALKED THE PT THROUGH TWO CONSECUTIVE CONTROL SOLUTION TESTS WHICH FELL OUTSIDE OF THE SPECIFIED CONTROL SOLUTION RANGE. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN