BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FLASH

    MDR report key: 575811 · Received February 14, 2005

    Report

    Report Number
    2954323-2005-00035
    Event Type
    Malfunction
    Date Received
    February 14, 2005
    Date of Event
    January 24, 2005
    Report Date
    February 11, 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 300, 150, 350 AND 461 MG/DL WITHIN 10 MINUTES. 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 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. NA 0417731

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN