BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1190665 · Received October 6, 2008

    Report

    Report Number
    2954323-2008-02678
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 10, 2008
    Report Date
    October 6, 2008
    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

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. ADDITIONALLY, THE REPORTED READINGS WERE NOT FOUND IN THE DEVICE'S INTERNAL MEMORY LOG.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF "LO" (INDICATES A READING LESS THAN 20 MG/DL), 43 MG/DL AND 94 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 0800727

    Patients

    Seq Age Sex Outcome Treatment
    1 NI