BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1180786 · Received September 22, 2008

    Report

    Report Number
    2954323-2008-02587
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFORMED AND NO NEW ISSUES OR ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING IMPRECISE SEQUENTIAL READINGS ON THEIR FREESTYLE FREEDOM LITE METER. THE CUSTOMER REPORTED THAT THEY OBTAINED READINGS OF 22.0 MMOL/L AND 5.6 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.

    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 0814429

    Patients

    Seq Age Sex Outcome Treatment
    1 NI