BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1180799 · Received September 22, 2008

    Report

    Report Number
    2954323-2008-02600
    Event Type
    Malfunction
    Date Received
    September 22, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 22, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER WITH SERIAL NUMBER WAS RETURNED. THE READING HIGH COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION, AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. IT IS UNKNOWN IF THE CUSTOMER WASHED THEIR HANDS PRIOR TO TESTING, AND IF THEY ATE BETWEEN TESTS.

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL REPORTED THAT A CUSTOMER OBTAINED A READING OF 128 MG/DL ON THEIR BLOOD GLUCOSE METER AND COMPARED TO LAB RESULT OF 76 MG/DL. THE TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINUTES. THE RESULTS WHEN PLOTTED A PARKES ERROR GRID FELL INTO THE "C" ZONE. THE "C" ZONE RESULT SHOWS 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NI