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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Irritation (1941); Itching Sensation (1943); Burning Sensation (2146)

Event Date 05/19/2020

Event Type  Injury  

Event Description

I am contacting you regarding the dexcom g6 continuous glucose monitor and the adhesive which was changed at the end of 2019 by the company. For over five years i have been using this product without adverse effects and now, i am experiencing a severe, itching, and burning rash. Several members in a dexcom (b)(6) group have posted photos and reported the same irritation. We have received no word from the company on how they are addressing this issue. I am writing the fda as an advocate and also for help for this severe problem because i have been prescribed a cgm by my doctor to keep me from experiencing low glucose levels. It is a medical necessity and yet it is causing me severe burning and irritation. I have photos and have contacted dexcom but their only offer is to replace the device with the very same adhesive. Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10096361
• MDR Text Key: 193006477
• Report Number: MW5094728
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/24/2020
• Device Model Number: G6
• Device Lot Number: 5265569
• 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: 05/27/2020 Patient Sequence Number: 1