BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1122845 · Received August 14, 2008

    Report

    Report Number
    2954323-2008-02415
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 15, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ABBOTT DIABETES CARE IN, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER HAS BEEN REQUESTED FOR INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING IMPRECISE SEQUENTIAL READINGS ON THEIR FREESTYLE LITE METER. THE CUSTOMER REPORTED THAT THEY OBTAINED READINGS OF 1.8 MMOL/L AND 13.0 MMOL/L WITHIN A 10-MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FELL IN THE 'C' ZONE, RESULTS IN THIS ZONE ARE DEEMED CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE IN, USA NI 0810413

    Patients

    Seq Age Sex Outcome Treatment
    1 NI