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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Skin Irritation (2076); Burning Sensation (2146)

Event Date 08/25/2020

Event Type  Injury  

Event Description

Incredibly bad rash; i use the dexcom g6 and a couple of months ago i started getting red, raised bumpy dots that itch really bad and feel like they're burning.It has caused me to take off the sensor early the last 2 times i used them because it was so bad.The rash lasts a couple of weeks.I have read on (b)(6) that this is happening to a lot of dexcom g6 users and just recently started over the last few months, like me.I've used this product for 4 years and only recently started getting rashes.The (b)(6) posts state that dexcom recently changed the formula of the adhesive.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10477175
• MDR Text Key: 205339387
• Report Number: MW5096352
• 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: 08/27/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 63