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

1 Patient was 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: Lay User/Patient
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 91