BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2064739 · Received April 8, 2011

    Report

    Report Number
    3004753838-2011-00094
    Event Type
    Other
    Date Received
    April 8, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    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 MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PATIENT EXPERIENCED A BROKEN SENSOR WIRE. UPON REMOVING THE SENSOR, PATIENT'S MOTHER NOTICED THAT THE RETAINED SENSOR WIRE FRAGMENT WAS PROTRUDING FROM THE PATIENT'S SKIN. PATIENT'S MOTHER WAS ABLE TO REMOVE THE WIRE WITH HER FINGERS. NO MEDICAL INTERVENTION WAS REQUIRED, AND PATIENT WAS FINE AT THE TIME OF HIS MOTHER'S CALL TO DEXCOM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5019901

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other