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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Rash (2033); Skin Irritation (2076)

Event Date 03/01/2020

Event Type  Injury  

Event Description

I have been using dexcom cgm for over a year. This past (b)(6) i started getting very bad rashes from the cgm sensors. The rashes develop scabbing and you can clearly see the outline of the sensor and sensor components in the affected area. I read online that they changed the adhesive on the sensor in december 2019. I never had a rash from one of these until (b)(6) 2020. It has gotten so bad that i typically can only leave a sensor on for 3-5 days of the 10 days these sensors are fda approved for. The last one that i just removed was only used approx 28 hours before the itching got to be too much to take. Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10319834
• MDR Text Key: 200451682
• Report Number: MW5095695
• 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: 07/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/23/2020
• 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