BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1981861 · Received February 8, 2011

    Report

    Report Number
    2954323-2011-01527
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    April 12, 2011
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER SERIAL NUMBER (B)(4) AND TEST STRIPS LOT NUMBER 1018911 HAVE BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED. AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TESTS RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY.

    Additional Manufacturer Narrative · 1

    THIS IS A CORRECTION FOLLOW UP. FOLLOW UP NUMBER 1 IN HAD INCOMPLETE LOT NUMBER 101891. THE CORRECT LOT NUMBER IS 1018911.

    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

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 2.7 MMOL/L, 6 MMOL/L, 1.1 MMOL/L, AND 3.7 MMOL/L 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 1018911

    Patients

    Seq Age Sex Outcome Treatment
    1