BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1810183 · Received October 12, 2007

    Report

    Report Number
    2954323-2007-19385
    Event Type
    Malfunction
    Date Received
    October 12, 2007
    Date of Event
    September 13, 2007
    Report Date
    October 12, 2007
    Manufacturer
    ABBOTT DIABETES CARE, INC., USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND THE INVESTIGATION REVEALED THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPEC AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE PRESENCE OF THE READINGS ON THE REPORTED DATE AND THE VALIDITY OF THE TIME FRAME BETWEEN THE READINGS IS INDETERMINABLE AS THE DATE AND TIME IS SET INCORRECTLY IN THE METER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 71 MG/DL AND 368 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 BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE, INC., USA NI 0636325

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK