BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2982658 · Received February 28, 2013

    Report

    Report Number
    3004753838-2013-00051
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    January 31, 2012
    Report Date
    January 31, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT OVER THE PRIOR YEAR, HE HAD EXPERIENCED IRRITATION ON HIS ABDOMINAL SKIN UPON REMOVAL OF SENSORS. PATIENT REPORTED THAT HE IS EXPERIENCING ITCHY RASHES ON OTHER PARTS OF HIS BODY AS WELL. PATIENT CONSULTED DERMATOLOGIST IN (B)(6) 2013. DERMATOLOGIST ATTEMPTED TO DETERMINE IF PATIENT IS ALLERGIC TO AN INGREDIENT IN THE SENSOR PATCH ADHESIVE. ON (B)(4) 2013, DEXCOM TECHNICAL SUPPORT CONTACTED PATIENT TO FOLLOW UP. PATIENT REPORTED THAT NO RESULTS WERE YET AVAILABLE FROM DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88340 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other