BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 380930 · Received March 8, 2002

    Report

    Report Number
    2954323-2002-00021
    Event Type
    Malfunction
    Date Received
    March 8, 2002
    Date of Event
    February 28, 2002
    Report Date
    March 8, 2002
    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

    CALLER REPORTED ERRATIC RESULTS AND ERROR MESSAGE ERL (INSUFFICIENT SAMPLE APPLIED). WITHIN A FIVE MINUTE PERIOD, CALLER HAD RESULTS OF 444, 222, AND 90 MG/DL. CALLER WAS UNABLE TO COMPLETE CONTROL SOLUTION TEST AS CALLER WAS OUT OF SUPPLY. CALLER HAS TAKEN INCORRECT DOSE OF GLUCOPHAGE WITHOUT PROLONGED ILL EFFECT OR INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN