BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREESTYLE LITE

    MDR report key: 1742828 · Received June 30, 2010

    Report

    Report Number
    2954323-2010-00890
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 11, 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 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.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR ADC BLOOD GLUCOSE MONITOR WITHIN 10 MINUTES OF 29 MG/DL AND 291 MG/DL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSULIN LEAKED FROM THE RESERVOIR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1002033

    Patients

    Seq Age Sex Outcome Treatment
    1