BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1774932 · Received July 29, 2010

    Report

    Report Number
    2954323-2010-01006
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 24, 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 FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE CUSTOMER RETURNED METER (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 MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 28 MG/DL, 22 MG/DL AND 131 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES 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 SIMPLEX SET SO QUICKLY IN THE SURGERY. (OPERATION ROOM TEMP 23 DEGREES IN C, TOTAL SETTING TIME 6 MINS, STORAGE LIFE, 1 MONTH (25 DEGREES IN C). THE SURGERY WAS COMPLETED WITHOUT ANY HEALTH CONSEQUENCES TO THE PT AND NO DELAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1010523

    Patients

    Seq Age Sex Outcome Treatment
    1