BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5153582 · Received October 15, 2015

    Report

    Report Number
    3004753838-2015-81636
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 20, 2015
    Report Date
    September 21, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THERE WAS NO REPORTED ALLEGED DEVICE MALFUNCTION. IT SHOULD BE NOTED THAT THE DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM USERS GUIDE STATES: INSERTING THE SENSOR AND WEARING THE ADHESIVE PATCH MIGHT CAUSE INFECTION, BLEEDING, PAIN OR SKIN IRRITATIONS (REDNESS, SWELLING, BRUISING, ITCHING, SCARRING, OR SKIN DISCOLORATION).

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015, TO REPORT THAT ON (B)(6) 2015, THE PATIENT DEVELOPED A SKIN REACTION UNDER THE SENSOR ADHESIVE, DIRECTLY WHERE THE SENSOR TOUCHES THE SKIN. PATIENT DESCRIBED THE SKIN REACTION AS A RED, BURNING, SWOLLEN, ITCHY RASH. SENSOR WAS INSERTED AT ABDOMEN ON (B)(6) 2015. PATIENT REPORTED CONSULTING HIS DERMATOLOGIST ON (B)(6) 2015. DERMATOLOGIST ADVISED PATIENT TO DISCONTINUE DEXCOM USE. PHYSICIAN DID NOT PRESCRIBE PATIENT ANY MEDICATIONS. PATIENT TREATS THE AFFECTED AREA WITH OVER THE COUNTER ALCOHOL AND HYDROCORTISONE CREAM. AT THE TIME OF CONTACT, PATIENT REPORTED STILL HAVING A BURN-LIKE MARK AT THE SENSOR INSERTION SITE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684373 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5201532 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other