BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1060715 · Received June 10, 2008

    Report

    Report Number
    2954323-2008-02076
    Event Type
    Malfunction
    Date Received
    June 10, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ABBOTT DIABETES CARE, INC, USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A READING OF 394 MG/DL ON HIS FREESTYLE FREEDOM BLOOD GLUCOSE METER COMPARED TO A LABORATORY RESULT OF 113 MG/DL. THE TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE. THE "C" 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 NA 0804427

    Patients

    Seq Age Sex Outcome Treatment
    1 NA