BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 625650 · Received June 9, 2005

    Report

    Report Number
    2954323-2005-00245
    Event Type
    Malfunction
    Date Received
    June 9, 2005
    Date of Event
    May 30, 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

    A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS WAS RECEIVED ON A CUSTOMER'S FREESTYLE FLASH METER. THE CUSTOMER OBTAINED READINGS OF 123, 203, 85, 106, 335 AND 95 MG/DL WITHIN A TEN MINUTE TIMEFRAME. WHEN PLOTTING EACH VALUE AGAINST THE AVERAGE ON A PARKES ERROR GRID ONE RESULT FALLS IN THE 'C' ZONE SHOWING THE DIFFERENCE TO BE CLINICALLY SIGNIFICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. * 0418306

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN