BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 2042508 · Received April 6, 2011

    Report

    Report Number
    2954323-2011-02837
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 19, 2011
    Report Date
    May 25, 2011
    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 SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: IT IS UNKNOWN WHICH READINGS WERE OBTAINED ON WHICH TEST STRIP LOT.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED ON RETURNED METER (B)(4) WITH RETAINED TEST STRIPS. 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; BUT NOT WITHIN A 10-MINUTE TIMEFRAME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER WHILE USING TEST STRIP LOTS 1083636 AND 1017540. CUSTOMER REPORTED RECEIVING READINGS OF 26 MG/DL, 101 MG/DL, AND 29 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 1083636

    Patients

    Seq Age Sex Outcome Treatment
    1