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

Model Number G6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); No Code Available (3191)

Event Date 05/15/2020

Event Type  Injury  

Event Description

The dexcom g-6 has a problem with the adhesive on the sensor.I have been using it for almost 2 years and it just started in (b)(6) 2020.They say they switched adhesive formulas and it could now cause a skin irritation.I have used 4 new ones and it causes a severe irritation on the skin.The bumps are so bad they force the sensor off the skin.The company says to start using skin barrier.I have and the result was even worse.They said that they have no plans to fix the problem.This adhesive is leaving welts under the patch.I do not and never have had allergies to plastic or adhesives.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10232682
• MDR Text Key: 197760821
• Report Number: MW5095352
• 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: 06/30/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 132