BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESTYLE

    MDR report key: 611840 · Received May 30, 2005

    Report

    Report Number
    2954323-2005-00199
    Event Type
    Malfunction
    Date Received
    May 30, 2005
    Date of Event
    May 18, 2005
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING INACCURATE ERRATIC READINGS. IN BLOOD GLUCOSE TESTS, CUSTOMER RECEIVED READINGS OF 100, 221, 365, AND HI (OR 501+) WITHIN 10 MINUTES THEN 73 MG/DL AFTER DOSING WITH INSULIN. THE RESULTS WITHIN 10 MINUTES, WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE 'C' ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY. OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. * 0502416

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN