BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR

    MDR report key: 2253962 · Received September 16, 2011

    Report

    Report Number
    3004753838-2011-00256
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    June 4, 2011
    Report Date
    August 2, 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

    PT'S MOTHER CALLED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2011 TO REPORT THAT PT HAS SOUGHT MEDICAL INTERVENTIONAL DUE TO A RASH THAT APPEARS AROUND THE ADHESIVE PATCH AND THAT LATER DEVELOPS INTO A YELLOW CRUST WHICH CAUSES THE ADHESIVE PATCH TO PEEL OFF PREMATURELY. PT'S MOTHER STATED THAT THE RASH HAS BECOME PROGRESSIVELY WORSE WITH EVERY SENSOR WEAR AND HAS TAKEN LONGER TIME TO HEAL. PT'S MOTHER CONSULTED WITH PT'S PHYSICIAN WHO RECOMMENDED THAT THEY USE AN INTERMEDIARY ADHESIVE. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PT'S MOTHER REPORTS THAT PT WAS DOING FINE AND THAT THE ADHESION SITE WAS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SENSOR MDS DEXCOM, INC. 9500-03 5016161

    Patients

    Seq Age Sex Outcome Treatment
    1 34 MO Other