BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 1862260 · Received October 8, 2010

    Report

    Report Number
    2954323-2010-01406
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 17, 2010
    Report Date
    March 30, 2012
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ADDITIONALLY: DURING TROUBLESHOOTING WITH CUSTOMER SERVICE, CUSTOMER WAS ASKED TO REMOVE THE BATTERIES AND REPEAT THE INSTALLATION PROCEDURE AT THE PROMPTING OF THE AGENT. AFTER THE CUSTOMER PERFORMED THE REPEAT INSTALLATION THE BLANK SCREEN ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 1

    THE RECEIVER WAS RETURNED AND INVESTIGATED. VISUAL INSPECTION OBSERVED BROKEN BATTERY CONTACT, THE RECEIVER DID NOT POWER ON WITH BUTTON DEPRESSION AND STRIP INSERTION DURING INITIAL TESTING DUE TO BROKEN BATTERY CONTACT. ALTHOUGH , THE RECEIVER DID NOT POWER ON, PER LABEL COPY THE USER IS INSTRUCTED TO CALL CUSTOMER CARE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED NOTICING A BLANK SCREEN ON THE DISPLAY OF HIS FREESTYLE NAVIGATOR CONTINUOUS MONITORING SYSTEM'S RECEIVER. HE FURTHER REPORTED REPLACING THE BATTERIES BUT THE PROBLEM CONTINUED SO HE STOPPED WEARING THE SYSTEM ON (B)6) 2010. IT WAS FURTHER REPORTED THAT ON (B)6) 2010 THE CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS AFTER STEPPING OUT OF THE SHOWER. PARAMEDICS WERE CALLED, CHECKED HIS BLOOD GLUCOSE (READING NOT PROVIDED) AND ADMINISTERED A GLUCAGON INJECTION. CUSTOMER ALSO SELF-TREATED WITH FOOD. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R