BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2210080 · Received August 2, 2011

    Report

    Report Number
    3004753838-2011-00229
    Event Type
    Other
    Date Received
    August 2, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 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 HER SKIN UPON REMOVAL OF SENSOR DUE TO A PAINFUL INSERTION FOLLOWED BY A DISCOMFORT AND A NAGGING IRRITATION DURING SENSOR WEAR. PT WAS ABLE TO PULL OUT BROKEN MATERIAL FROM HER SKIN WITH TWEEZERS. PT BELIEVES THAT THE 3-4 MM LONG MATERIAL THAT WAS LODGED IN HER SKIN WAS A PIECE OF THE INSERTION NEEDLE AND NOT A BROKEN PIECE OF THE SENSOR WIRE. PT REPORTS THAT THE PAIN AND DISCOMFORT SUBSIDED AFTER REMOVING THE SENSOR AND PULLING THE BROKEN MATERIAL OUT OF HER SKIN. PT DID NOT REQUIRE MEDICAL INTERVENTION AND HAS STARTED A NEW AND SUCCESSFUL SENSOR SESSION. DURING HER 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 5015570

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other