BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1614297 · Received February 24, 2010

    Report

    Report Number
    2954323-2010-00205
    Event Type
    Malfunction
    Date Received
    February 24, 2010
    Date of Event
    January 31, 2010
    Report Date
    February 24, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ((B) (4)) HAS BEEN RETURNED AND AN INVESTIGATION UTILIZING THE RETURNED METER, RETURNED TEST STRIPS (LOT NO: 0932522) AND RETAINED CONTROL SOLUTION (LOT NO: 9F1P11) HAS DETERMINED THE COMPLAINT IS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. ADDITIONALLY, A REVIEW OF THE METER'S INTERNAL MEMORY LOG REVEALED THE PRESENCE OF THE REPORTED RESULTS. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HIS FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 487 MG/DL AND 145 MG/DL 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0932522

    Patients

    Seq Age Sex Outcome Treatment
    1