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

Model Number G6

Device Problem Product Quality Problem (1506)

Patient Problems Erythema (1840); Irritation (1941); Itching Sensation (1943); Swelling (2091); Reaction (2414)

Event Date 06/12/2020

Event Type  Injury  

Event Description

As a type 1 diabetic, i use dexcom g6 sensors to monitor my blood sugar levels. I've used dexcom products for six years, but i've started continuously experiencing adverse side effects from the product as of 1. 5 months ago. The blood sugar sensor is attached to my skin through a small oval of gauze with an adhesive to make sure it stays attached to my body for 10 days. For the past six sensor applications, as soon as i attach the gauze with adhesive to my stomach, the skin underneath and around the application site immediately break out into small, red bumps which become incredibly itchy and irritating. The irritating sensation lasts the entire 10 days in which the sensor is attached to my skin. When i remove the gauze and adhesive, the skin underneath is bright red, covered in bumps, and dry. The dryness and irritation lasts approximately one week after i remove the sensor. I have tried changing the positions in which i apply the sensor, and the same result happens in every location. Because of this, my abdomen is covered in red, irritating, dry patches. I need the sensor to accurately monitor my blood sugar, but these side effects are making it very difficult to do so. I believe dexcom changed the adhesive on their gauze and now my skin is having an adverse reaction to the adhesive. Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSORS
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10189043
• MDR Text Key: 196414500
• Report Number: MW5095166
• Device Sequence Number: 6
• 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: 06/19/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

0 Patients were Involved in the Event:

• Date FDA Received: 06/23/2020
• 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?: No Answer Provided
• 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