BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2925869 · Received January 22, 2013

    Report

    Report Number
    3004753838-2013-00023
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 27, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    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

    A CLINICIAN CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT UPON REMOVAL OF SENSOR FROM TRIAL PATIENT ON (B)(6) 2012, THE WIRE REMAINED PROTRUDING FROM SENSOR INSERTION SITE. THE PATIENT'S MOTHER WAS ABLE TO REMOVE THE WIRE FROM PATIENT'S SKIN. AT THE TIME OF THE CALL TO TECHNICAL SUPPORT, PATIENT WAS IN FINE CONDITION. PATIENT'S MOTHER REPORTED NO DISCOMFORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31126 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other