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

Device Problem Product Quality Problem (1506)

Patient Problems Rash (2033); Skin Irritation (2076); Reaction (2414)

Event Date 08/29/2020

Event Type  Injury  

Event Description

I am a type 1 diabetic and i use a dexcom g6. The last sensor had some issues and i thought it was a fluke but when i switch to a new sensor i had the same issues. My skin broke out into a very irritated rash. It is excruciatingly irritated. Dexcom never warned me that they were using a new adhesive. I have never in my life had a negative reaction to any adhesive and i do not have sensitive skin at all. Diabetics are prone to infection and complications involved in healing. I am left with blisters. 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: 10482392
• MDR Text Key: 205495984
• Report Number: MW5096373
• Device Sequence Number: 2
• 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: 08/29/2020
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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