BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEDOM LITE

    MDR report key: 1541985 · Received November 20, 2009

    Report

    Report Number
    2954323-2009-02057
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    November 6, 2009
    Report Date
    July 12, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE IS RETURNED AND INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER (B) (4) AND STRIP LOT 0922536 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 ON THE DAY OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 60.5 MONTHS. ON (B) (6) 2010 (THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER), IT WAS LEARNED THAT THE DEVICE WAS EXPLANTED DUE TO MITRAL STENOSIS, SECONDARY TO CALCIFICATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HE RECEIVED THE FOLLOWING ERRATIC READINGS ON HIS BLOOD GLUCOSE METER WITHIN 10 MINUTES: 183 MG/DL, 30 MG/DL AND 65 MG/DL. RESULTS WERE PLOTTED ON A PARKES ERROR GRID AND 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0922536

    Patients

    Seq Age Sex Outcome Treatment
    1