BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1060731 · Received June 11, 2008

    Report

    Report Number
    2954323-2008-02088
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 11, 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 CUSTOMER'S PRODUCT HAS BEEN RETURNED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATIONS AND ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS REPORTED WERE FOUND IN THE METER LOG: DATE (MM/DD): TIME (H): 18:29; READINGS (MG/DL): 126. DATE (MM/DD): TIME (H): 18.28, READING (MG/DL) 387.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING IMPRECISE READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 387 MG/DL AND 126 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON THE PARKES ERROR GRID FELL INTO THE "C" ZONES 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 LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 0735517

    Patients

    Seq Age Sex Outcome Treatment
    1 NI