BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1526449 · Received November 13, 2009

    Report

    Report Number
    2954323-2009-02003
    Event Type
    Malfunction
    Date Received
    November 13, 2009
    Date of Event
    October 26, 2009
    Report Date
    January 7, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B) (4) AND STRIP LOT 0920322 WERE RETURNED FOR INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN THE METER 'S MEMORY HOWEVER, SEVERAL WERE LOCATED OUTSIDE THE TEN-MINUTE TIMEFRAME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES OF 136 MG/DL, 112 MG/DL, 170 MG/DL, 138 MG/DL, 163 MG/DL, 111 MG/DL AND 499 MG/DL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION ELBOW ARTHROPLASTY IN 2009 TO REMOVE AND REPLACE THE POLY ULNA BEARING. DURING THE PROCEDURE, UNSUCCESSFUL ATTEMPTS WERE MADE TO REPLACE ULNA BEARING, AND THE PATIENT RETURNED TO SURGERY THE NEXT DAY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0920322

    Patients

    Seq Age Sex Outcome Treatment
    1