BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2101444 · Received May 2, 2011

    Report

    Report Number
    3004753838-2011-00128
    Event Type
    Injury
    Date Received
    May 2, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    DEXCOM, INC.,
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    PT'S NURSE PRACTITIONER CONTACTED DEXCOM'S SALES ON (B)(6) 2011 TO REPORT THAT PT EXPERIENCED SERIOUS IRRITATION FROM THE SENSOR ADHESIVE PATCH. PT HAS BEGUN TO DEVELOP BAD RASHES FROM THE ADHESIVE. DURING A F/U CALL BY DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, PT'S FATHER CLARIFIED THAT PT DEVELOPS ITCHING AT THE SITE APPROXIMATELY 1-2 DAYS AFTER INSERTION. THE SITE IS RED UPON SENSOR REMOVAL, WITH THE RASH OR REDNESS OCCURRING ONLY AROUND THE ADHESIVE AREA. PT'S PARENTS VISITED THE PT'S ENDOCRINOLOGIST, WHO PRESCRIBED A CREAM AND OINTMENT THAT HAVE HELPED ALLEVIATE AND CLEAR UP THE SITES OF IRRITATION. PT STOPPED USE OF THE DEVICE OVER A MONTH AGO PER THE ENDOCRINOLOGIST'S RECOMMENDATION TO GIVE THE SKIN TIME TO HEAL. PT'S PARENTS PLAN ON RETURNING TO THE DEVICE WHEN THEY FEEL IT IS APPROPRIATE TO DO SO. PT WAS FINE BUT STILL HAD SOME MARKS AT THE AFFECTED SITES AT THE TIME OF HER FATHER'S F/U CALL WITH 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

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other