BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1897054 · Received November 11, 2010

    Report

    Report Number
    2954323-2010-01545
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 22, 2010
    Report Date
    December 29, 2010
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER (B)(4) AND STRIP LOT NUMBER 0922536. THE COMPLAINT WAS NOT CONFIRMED AND ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. IN ADDITION, THE READINGS REPORTED WERE NOT FOUND IN THE INTERNAL MEMORY LOG OF THE METER.

    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

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE INACCURATE ERRATIC WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 498 MG/DL AND 120 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 0922536

    Patients

    Seq Age Sex Outcome Treatment
    1