BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3405224 · Received October 10, 2013

    Report

    Report Number
    3004753838-2013-00293
    Event Type
    Malfunction
    Date Received
    October 10, 2013
    Date of Event
    September 1, 2012
    Report Date
    September 13, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEXCOM, INC. AND FDA AGREED DURING A FACILITY INSPECTION THAT ANY POSSIBLE BROKEN SENSOR WIRE WAS A REPORTABLE EVENT, EVEN IN THE ABSENCE OF ANY EVIDENCE OF PHYSICAL HARM OR NECESSITY FOR INTERVENTION.

    Description of Event or Problem · 1

    PATIENT¿S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT AN EVENT THAT HAS OCCURRED A YEAR AGO, AROUND (B)(6) 2012. PATIENT WAS EXTENDING THE USE OF THE DEVICE BEYOND THE APPROVED 7 DAYS WHEN SHE EXPERIENCED A BROKEN SENSOR. PATIENT WAS TAKEN TO THE HOSPITAL ON (B)(6) 2012 WHERE A FOREIGN BODY FRAGMENT, OF APPROXIMATELY 4 MM, WAS VISUALIZED IN AN X-RAY, IN THE PATIENT¿S RIGHT FEMUR. MEDICAL EXPERTS AGREED NOT TO INTERVENE SURGICALLY SINCE PATIENT WAS NOT SUFFERING FROM ANY OTHER ILLNESSES OR DISCOMFORTS RELATED TO THE FOREIGN OBJECT IN HER BODY. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, ONE YEAR AFTER THE EVENT, PATIENT¿S FATHER REPORTED THAT PATIENT WAS FEELING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515787 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03 5039462

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| O