BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1549069 · Received December 2, 2009

    Report

    Report Number
    2954323-2009-02088
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 11, 2009
    Report Date
    January 5, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 0913101 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 REPORTED READING OF 398MG/DL WAS FOUND IN THE METER'S MEMORY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 398 MG/DL AND 122 MG/DL WITHIN 10 MINUTES. 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 THE IMPLANTABLE NEUROSTIMULATOR INITIALLY PROVIDED PAIN RELIEF BUT LATER LOST EFFECTIVENESS; IT NO LONGER PROVIDES PAIN RELIEF AND HAS BEEN TURNED OFF. IT IS UNKNOWN IF ANY DEVICE TROUBLESHOOTING WAS PERFORMED. SURGICAL INTERVENTION (UNSPECIFIED) WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0913101

    Patients

    Seq Age Sex Outcome Treatment
    1