BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1778196 · Received July 31, 2010

    Report

    Report Number
    2954323-2010-01019
    Event Type
    Malfunction
    Date Received
    July 31, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 24, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE CUSTOMER RETURNED METER SERIAL NUMBER (B)(4). THE METER HAS BEEN TESTED WITH AN APPROVED STRIP LOT 1002834. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, THE READINGS REPORTED WERE FOUND IN THE INTERNAL MEMORY LOG OF THE METER AND WERE TAKEN IN 10 MINUTES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 433 MG/DL AND 135 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

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS VENTRICULAR LEAD WAS EXHIBITING INCREASED THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. IT WAS SUSPECTED THAT THE LEAD MAY HAVE DISLODGED GOING INTO THE LEAD REVISION. ATTEMPTS TO REPOSITION THE LEAD WERE UNSUCCESSFUL AS THE THRESHOLDS WERE STILL INCREASED. THE PHYSICIAN REQUESTED A NEW LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1010424

    Patients

    Seq Age Sex Outcome Treatment
    1