BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1811767 · Received August 23, 2010

    Report

    Report Number
    2954323-2010-01154
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 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. NOTE: THE METER IS DESIGNED TO REPORT READINGS OF 20 MG/DL TO 500 MG/DL. IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE NUMERIC VALUE FOR READINGS GREATER THAN 500 MG/DL. A "HI" DISPLAY MESSAGE INDICATES A READING GREATER THAN 500 MG/DL.

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCTS HAVE BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READING OF 115MG/DL REPORTED BY THE CUSTOMER WAS FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES. RESULTS OF 501 MG/DL AND 115 MG/DL WERE PLOTTED ON THE PARKES ERROR GRID. THE RESULTS 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD EXHIBITED A RISE IN PACING IMPEDANCE MEASUREMENTS FROM 340 OHMS TO GREATER THAN 3000 OHMS. RV CHANNEL SENSING AND CAPTURE REMAIN ACCEPTABLE, AND NO NOISE HAS BEEN OBSERVED WITH ISOMETRIC TESTING. OF NOTE, THE PATIENT'S DEVICE IS A COMPETITIVE PRODUCT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1011714

    Patients

    Seq Age Sex Outcome Treatment
    1