BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1083753 · Received July 24, 2008

    Report

    Report Number
    2954323-2008-02329
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 3, 2008
    Report Date
    July 24, 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

    THIS PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION, AND A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING IMPRECISE READINGS ON THEIR FREESTYLE LITE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 60 MG/DL, 340 MG/DL AND 250 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 LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NI 0712024

    Patients

    Seq Age Sex Outcome Treatment
    1 NI