BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE

    MDR report key: 1211286 · Received October 20, 2008

    Report

    Report Number
    2954323-2008-02739
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 20, 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 IS AN INITIAL REPORT. THE DEVICE HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING AN INACCURATELY HIGH READING ON HIS FREESTYLE METER AS COMPARED TO A LABORATORY METER. CUSTOMER RECEIVED A READING OF 223 MG/DL COMPARED TO A LAB READING OF 100 MG/DL WITHIN A 10-MINUTE TIMEFRAME. 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 BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NI 8017201

    Patients

    Seq Age Sex Outcome Treatment
    1 NI