BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2133737 · Received June 17, 2011

    Report

    Report Number
    3004753838-2011-00183
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 19, 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 CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT OVER THE LAST FIVE MONTHS SHE'S EXPERIENCED IRRITATION ("RED RASH, ALMOST LIKE BURN MARKS") WITHOUT FLUID OR INFECTION. THE AFFECTED AREA TAKES ABOUT 2 WEEKS TO HEAL. PT REPORTED THAT IRRITATION SEEMS TO BE AN ALLERGIC REACTION CAUSED BY THE POD ADHESIVE. PT CONSULTED HER ENDOCRINOLOGIST AROUND (B)(6) 2011 AND CLINICAL DIABETES EDUCATOR WHO ADVISED TO USE NEOSPORIN ON AFFECTED AREA. PT HAD TRIED USING IV 3000 WITH NO SUCCESS.

    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 21 YR Other