BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1438475 · Received April 14, 2009

    Report

    Report Number
    2954323-2009-00457
    Event Type
    Malfunction
    Date Received
    April 14, 2009
    Date of Event
    March 16, 2009
    Report Date
    April 14, 2009
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 449, 120, 174, 173, 123 AND 97 WHICH WERE ALL IN MG/DL AND WITHIN 10 MINUTES. 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC., USA NA 0722536

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK