BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1521236 · Received October 22, 2009

    Report

    Report Number
    2954323-2009-01893
    Event Type
    Malfunction
    Date Received
    October 22, 2009
    Date of Event
    September 28, 2009
    Report Date
    October 22, 2009
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE (B)(4) AND TEST STRIPS (LOT NO: 0823813) HAVE BEEN RETURNED AND AN INVESTIGATION USING APPROVED CONTROL SOLUTION HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. ADDITIONALLY, A REVIEW OF THE METER'S INTERNAL MEMORY LOG REVEALED RESULTS OF 122 MG/DL, LO AND 306 MG/DL, WHICH WERE OBTAINED WITHIN A 10 MINUTE TIME FRAME. IT SHOULD BE NOTED: THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS LESS THAN 20 MG/DL. A "LO" DISPLAY MESSAGE INDICATES A READING LESS THAN 20 MG/DL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 356 MG/DL, "LO" AND 114 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS 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 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0823813

    Patients

    Seq Age Sex Outcome Treatment
    1 NI