BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2210086 · Received August 2, 2011

    Report

    Report Number
    3004753838-2011-00228
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT A WIRE WAS PROTRUDING FROM HIS SKIN UPON REMOVAL OF SENSOR DUE TO A SENSOR FAILURE. PT WAS ABLE TO PULL OUT BROKEN SENSOR FROM HIS SKIN WITH TWEEZERS BUT PT BELIEVES THAT THE TIP OF THE SENSOR IS STILL IN HIS SKIN. PT OBSERVES A RED SPOT AT SITE OF INSERTION AND TENDERNESS. PT HAS NOT SOUGHT MEDICAL INTERVENTION. ALTHOUGH PT WAS CONCERNED DURING HIS CALL TO DEXCOM TECHNICAL SUPPORT, PT REPORTS FEELING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5015648

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other