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

Device Problems Loss of or Failure to Bond (1068); Device Emits Odor (1425)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074); Skin Irritation (2076); Swelling (2091); Reaction (2414)

Event Date 03/25/2020

Event Type  Injury  

Event Description

My daughter has used her dexcom g6 for 2 years and never had a problem. Then one day she said it started to itch. We looked at it, the spot where her sensor was and it was falling off. Once again never had a problem. The sensor only stayed on for a little bit, and then we switched her arm. When we switched it, she had bumps on her arm where her sensor was previously. Then we put it on her other arm and when we took it off, she had this bright red mark that was the entire length and width of the sensor. We called dexcom and they told us to get a skin barrier. We tried that and it didn't work. Her skin was still bright red, it started to peel. I looked online and found out in a type 1 diabetes chat room that dexcom had changed the glue on their patches december 2019 without notification. My daughter has type 1 diabetes along with celiac's disease and so i called to find out if there was flaw in the new glue but they wouldn't tell me what was in the solution. They said i should call her primary physician which i did. Her doctor said that her skin had gone through a shock. It is extra sensitive now and anything that was applied to it could give a reaction. She also had red bumps on her legs now. After putting the patches on, and her skin bubbling up underneath the patch and smelling so bad, we knew something had to be done. So, my husband and i decided to use a patch underneath the dexcom g6, that we had bought and were using on top of it to hold it. It is working currently but she still has red marks when we change the sensor. They aren't as bad but they are still there. The frustrating part is when i call dexcom and express my frustration, they say the glue change is only effecting 1% of our patients, sorry you're in the 1%. Also, they say they are going to send the recorded call, then their manager to review so we can get help and no one has followed up. It is (b)(6) and we've been calling since (b)(6). We really like the product, we just wish they would give us an option of using the old glue or using the new glue. The old glue seemed to be fine on her skin. Fda safety report id# (b)(4).

• Brand Name: G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10514193
• MDR Text Key: 206556565
• Report Number: MW5096515
• Device Sequence Number: 1
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No Answer provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 09/09/2020 Patient Sequence Number: 1