BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 561852 · Received May 18, 2004

    Report

    Report Number
    2939301-2004-03159
    Event Type
    Malfunction
    Date Received
    May 18, 2004
    Report Date
    May 10, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT CALLED LFS AND ALLEGED THAT THEIR METER WAS READING INACCURATELY HIGH. THE PT REPORTED BLOOD GLUCOSE RESULTS OF 149, 326, 93, 130, 119, AND 149 MG/DL WITH A LIFESCAN METER AND 119, 302, 88, 120, 98, AND 123 MG/DL ON A LAB DEVICE, PERFORMED WITHIN 10 MINUTES 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 DOES NOT EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE TEST STRIPS WERE IN GOOD CONDITION, CODES MATCHED, AND THE TESTING TECHNIQUE WAS CORRECT. THE PT PERFORMED TWO CONTROL SOLUTION TESTS, WHICH FAILED. A NEW METER IS BEING SENT TO THE PT. BASED ON THE TWO CONTROL TESTS FAILING, THERE IS EVIDENCE OF METER MALFUNCTION. THERE IS NO EVIDENCE OF A SERIOUS INJURY. NO FURTHER INFO HAS BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN