BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRA

    MDR report key: 802172 · Received November 30, 2004

    Report

    Report Number
    2939301-2004-05990
    Event Type
    Malfunction
    Date Received
    November 30, 2004
    Report Date
    November 24, 2004
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    A PT REPORTED BLOOD GLUCOSE RESULTS OF 132 MG/DL WITH A LIFESCAN METER AND 192 MG/DL ON A LABORATORY 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 EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY, THEREBY INDICATING A POTENTIAL MALFUNCTION OF THE METER IN TERMS OF ACCURACY. THE PT RETESTED ON THE REPORTED METER AND OBTAINED BG RESULTS OF 212, 246, 179 AND 219 MG/DL WITH A 15% VARIANCE BETWEEN THE FOUR RESULTS. METER AND TEST STRIPS WERE REPLACED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2526432

    Patients

    Seq Age Sex Outcome Treatment
    1 YR