BEUDAMED
    FDA Adverse Event Other Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 1628709 · Received February 24, 2010

    Report

    Report Number
    3004753838-2010-00075
    Event Type
    Other
    Date Received
    February 24, 2010
    Date of Event
    February 8, 2010
    Report Date
    February 24, 2010
    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. DURING PT'S INITIAL CALL TO DEXCOM TECHNICAL SUPPORT, PT WAS ADVISED, PER SCRIPT, THAT IN THE RARE INSTANCES WHEN A BROKEN SENSOR WIRE POSSIBLY UNDERNEATH THE SKIN HAS OCCURRED IN THE PAST, CONSULTING PHYSICIANS AND SURGEONS HAVE RECOMMENDED NOT TO REMOVE THE WIRE FRAGMENT FROM THE SKIN AS LONG AS THERE ARE NO SYMPTOMS OF INFECTION OR INFLAMMATION. IN THE EVENT THAT SIGNS AND/OR SYMPTOMS OF INFECTION OR INFLAMMATION ARISE, SUCH AS REDNESS, SWELLING, OR PAIN, PT WAS ADVISED TO CONSULT WITH THE PRESCRIBING PHYSICIAN FOR THE BEST WAY TO PROCEED. PT WAS FURTHER ADVISED THAT IF THERE IS NO PORTION OF THE BROKEN WIRE FRAGMENT VISIBLE ABOVE THE SKIN, ATTEMPTS TO REMOVE WITHOUT MEDICAL GUIDANCE WERE NOT RECOMMENDED.

    Description of Event or Problem · 1

    PT CONTACTED DEXCOM ON (B)(6) 2010 TO REPORT THAT SHE HAD EXPERIENCED A POSSIBLE BROKEN SENSOR WIRE WITH A RETAINED DISTAL END. THE SUSPECT SENSOR WAS RETURNED TO DEXCOM ON (B)(6) 2010. LAB INVESTIGATION REVEALED THAT THE RETURNED SENSOR WAS COMPLETELY INTACT AND COULD NOT HAVE BROKEN OFF UNDER PT'S SKIN. PT'S INITIAL COMPLAINT REPORTED NO DIFFICULTY WITH THE INSERTION PROCESS. PT RECEIVED READINGS WITHOUT ISSUE FOR 5-6 DAYS UNTIL SHE RECEIVED AN EARLY SENSOR SHUTOFF ("ESS") NOTIFICATION ON DAY SIX OF HER SESSION. UPON REMOVING THE SENSOR, PT NOTICED "A SMALL BLACK FLECK" AT THE POINT OF INSERTION. PT BELIEVED THE BLACK FLECK WAS EITHER A PIECE OF THE SENSOR WIRE OR A BIT OF DRIED BLOOD. PT VISITED HER PRIMARY CARE PHYSICIAN AND EXPRESSED HER CONCERN. PT'S PHYSICIAN EXAMINED THE SITE AND ADVISED PT THAT THE SITE LOOKED FINE, BUT TO KEEP AN EYE ON IT FOR POSSIBLE INFECTION. DEXCOM TECHNICAL SUPPORT MADE A FOLLOW-UP CALL TO PT ON (B)(6) 2010 TO INFORM HER THAT NO BREAK HAD OCCURRED. PT REPORTED THAT THE INJECTION SITE HEALED NORMALLY AND SHE WAS JUST BEING "OVERLY NERVOUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5006532

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other