BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE NAVIGATOR

    MDR report key: 3942548 · Received July 17, 2014

    Report

    Report Number
    2954323-2014-00779
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Product Code
    MDS
    PMA / PMN Number
    P050020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE SERIAL NUMBER IS UNKNOWN; HENCE THE DATE OF MANUFACTURE IS ALSO UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    AN ADC REPRESENTATIVE NOTIFIED CUSTOMER SERVICE THAT A FREESTYLE NAVIGATOR CUSTOMER HAD CONTACTED HER ON (B)(6) 2014 TO ASK HER AN UNSPECIFIED "GENERAL QUESTION" ABOUT THE PRODUCT AND DURING THE CONVERSATION REPORTED THAT ON (B)(6) 2014 SHE INSERTED A NEW SENSOR, BUT THE CALIBRATION FAILED SO SHE WENT TO SLEEP WITH NO DATA FROM THE SENSOR. THE NEXT MORNING ((B)(6) 2014) A FAMILY MEMBER FOUND HER UNCONSCIOUS AND CALLED THE PARAMEDICS. UPON ARRIVAL THEY RECEIVED A READING OF 20 MG/DL ON THEIR UNSPECIFIED METER AND TRANSPORTED HER TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS TREATED WITH A GLUCAGON INJECTION IN ADDITION TO RECEIVING GLUCOSE VIA INTRAVENOUS INFUSION. CUSTOMER WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY TWO HOURS LATER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418434 FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM MDS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R