MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 SENSOR; SENSOR, GLUCOSE, INVASIVE

Device Problems Patient-Device Incompatibility (2682); Device Ingredient or Reagent Problem (2910)

Patient Problems Erythema (1840); Itching Sensation (1943); Scar Tissue (2060); Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)

Event Date 10/21/2020

Event Type  Injury  

Event Description

I am a type i diabetic and use a dexcom g6.I started using them almost three years ago.After about a year, i noticed problems with the sites where i had injected my dexcom.The sites were really red, were itchy, and then began to look like i had been burned.I called dexcom and spoke to a representative who told me that they had changed the adhesive that they were using on the dexcom, and that several customers were having a reaction causing an almost chemical burn.I was advised to clean the area well.I then went to an online dexcom support group that i belong to and posted about what i was told.Several members replied that they were told the same thing.I did learn to use spray benadryl or flonase to help.So now, i clean my sites twice with alcohol swabs, then spray with spray benadryl, letting all three dry, then i swab with skin tac and let it get tacky (sticky) so that i can then insert my dexcom and hopefully not suffer burns from the dexcom adhesive.I am thankful for my dexcom, and my tandem pump, but i am not sure that i am thankful for the scars that cover my body since i have been using these products.I have enough scars already: scar tissue from years of shots, pricking my fingers to test my blood sugars, and countless other problems because of my diabetes.I have had this disease for over 38 years.I have had to take thousands of shots, and have had to endure bruising from that.I have pricked my fingers millions of times to ensure that my blood sugars remained in normal levels.Having to now experience this is absolutely uncalled for.Human lives should be more important.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12087182
• MDR Text Key: 259182259
• Report Number: MW5102191
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/24/2021
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 66