BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2092930 · Received May 9, 2011

    Report

    Report Number
    3004753838-2011-00140
    Event Type
    Other
    Date Received
    May 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 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

    PT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT EXPERIENCED A FAILED SENSOR. WHEN THE SENSOR WAS REMOVED, THE SENSOR WIRE WAS PROTRUDING FROM THE SKIN. PT'S MOTHER WAS ABLE TO PULL THE WIRE OUT. THERE WAS NO SIGN OF REDNESS OR INFECTION AT THE INSERTION SITE. NO MEDICAL INTERVENTION WAS REQUIRED, AND PT 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 5015542

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other