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

Model Number G6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Date 05/15/2020

Event Type  Injury  

Event Description

The dexcom g-6 has a problem with the adhesive on the sensor. I have been using it for almost 2 years and it just started in (b)(6) 2020. They say they switched adhesive formulas and it could now cause a skin irritation. I have used 4 new ones and it causes a severe irritation on the skin. The bumps are so bad they force the sensor off the skin. The company says to start using skin barrier. I have and the result was even worse. They said that they have no plans to fix the problem. This adhesive is leaving welts under the patch. I do not and never have had allergies to plastic or adhesives. Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10232682
• MDR Text Key: 197760821
• Report Number: MW5095352
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• 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: 06/30/2020
• 4 Devices were Involved in the Event: 1 2 3 4

0 Patients were Involved in the Event:

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: G6
• 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?: No

Type of Device Usage