BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1630876 · Received March 15, 2010

    Report

    Report Number
    2954323-2010-00310
    Event Type
    Injury
    Date Received
    March 15, 2010
    Date of Event
    February 15, 2010
    Report Date
    July 7, 2010
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S RECEIVER WAS RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO OBSERVATIONS WERE NOTED. RETURNED METER POWERED ON WITH RIGHT BUTTON DEPRESSION AND TEST STRIP INSERTION. THIS IS A FINAL REPORT.

    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 INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    1. A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO ERRONEOUS LOW VANCOMYCIN (VANC) RESULT GENERATED BY SYNCHRON LX20 PRO ANALYZER.2. THE SAMPLE WAS RERUN AND HIGHER RESULT WAS OBTAINED. THE INITIAL AND REPEAT RESULTS ARE PROVIDED IN SECTION B63. THE ERRONEOUS RESULT WAS NOT REPORTED OUT OF THE LABORATORY.4. PATIENT TREATMENT WAS NOT IMPACTED BASED ON THE ERRONEOUS RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A BLANK SCREEN FROM HIS FREESTYLE NAVIGATOR RECEIVER DESPITE OF NEW BATTERY REPLACEMENT. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF HYPOGLYCEMIA, LIGHTHEADEDNESS, CONFUSION AND SEIZURE. NO SELF TREATMENT OR THIRD PARTY MEDICATION INTERVENTION WAS REPORT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM LFR 0825507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other