BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1181897 · Received September 19, 2008

    Report

    Report Number
    2954323-2008-02582
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 19, 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

    THIS IS AN INITIAL REPORT. THE METER HAS BEEN RETURNED, AND AN INVESTIGATION IS IN PROGRESS. 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 BLOOD GLUCOSE MONITOR WITH 10 MINUTES. RESULTS OF 222 MG/DL, 194 MG/DL, 191 MG/DL, 188 MG/DL, 57 MG/DL, 198 MG/DL, 202 MG/DL, 228 MG/DL, AND 112 MG/DL WERE PLOTTED ON A PARKES ERROR GRID. THE RESULTS FELL INTO THE "C" ZONES 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 0704726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA