BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2062748 · Received April 14, 2011

    Report

    Report Number
    3004753838-2011-00106
    Event Type
    Injury
    Date Received
    April 14, 2011
    Date of Event
    November 9, 2010
    Report Date
    January 13, 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 UNKNOWN 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

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT SHE WAS EXPERIENCING A HORRIBLE RASH AT THE SENSOR INSERTION SITE. PATIENT BELIEVED, THE RASH WAS A REACTION TO THE ADHESIVE PATCH. IN A FOLLOW-UP CALL MADE BY DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, PATIENT REPORTED THAT SHE CONTINUED TO EXPERIENCE SKIN IRRITATION (REDNESS AND WEEPING AT INSERTION SITE). PATIENT CONSULTED BOTH HER DERMATOLOGIST AND HER ENDOCRINOLOGIST. HER DERMATOLOGIST PRESCRIBED HYDROCORTISONE CREAM, WHICH PATIENT USES WHEN PLACING HER SENSORS. PATIENT REPORTED THAT SHE HAD ALSO BEEN USING AN OVER-THE-COUNTER KROGER PRODUCT THAT, ACCORDING TO A LOCAL GROCERY STORE, MAY HAVE BEEN CONTAMINATED WITH BACTERIA. DURING ANOTHER FOLLOW-UP CALL MADE BY DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011, PATIENT REPORTED THAT SHE NOW USES SKIN BARRIERS AND WIPES (IV 3000, ALL CARE BARRIER WIPES, AND SKIN TAC), WHICH ALL SEEM TO HELP. PATIENT ALSO REPORTED THAT SHE HAS SENSITIVE SKIN AND SEEMS TO HAVE ALLERGIC REACTIONS TO ALL ADHESIVES AND SURGICAL TAPES CONTAINING ACRYLATE.

    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 53 YR Other