BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 584639 · Received March 16, 2005

    Report

    Report Number
    2954323-2005-00072
    Event Type
    Malfunction
    Date Received
    March 16, 2005
    Date of Event
    March 1, 2005
    Report Date
    March 16, 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 45, 275, 200, 315 AND 225MG/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 BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN