BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1894300 · Received November 9, 2010

    Report

    Report Number
    2954323-2010-01535
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 21, 2010
    Report Date
    December 20, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS 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. TWO OF THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT PRESENTED TO THE HOSPITAL WITH A RUPTURED ANEURYSM AND WAS TREATED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. DURING THE PRE-PROCEDURE ANGIOGRAM, THE IMAGES SHOWED THE RUPTURED ANEURYSM AND AN EXTRAVASATION INTO THE ABDOMEN. THE PROCEDURE ENDED WITH NO REPORTED COMPLICATIONS. THE FINAL ANGIOGRAM IMAGES NO LONGER REVEALED THE EXTRAVASATION AND NO ENDOLEAKS WERE NOTED. THE PT WAS TRANSFERRED TO THE ICU FOR RECOVERY. WHILE IN THE ICU, THE PT BEGAN TO CODE AND GO INTO CARDIAC ARREST. LATER THAT DAY, THE PT EXPIRED. THE CAUSE OF DEATH IS UNK. NO FURTHER INFO IS AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 38 MG/DL, 55 MG/DL, AND 125 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 0918825

    Patients

    Seq Age Sex Outcome Treatment
    1