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

Model Number 9500-45

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Irritation (2076)

Event Date 07/06/2020

Event Type  Injury  

Event Description

Skin irritation due to the adhesive on the dexcom g6 sensor.I am using a barrier, as i have been since i started using the system in (b)(6) 2019, but the last two boxes of product(3 pack) have been causing skin irritation after 1-2 days of wear.The sensors are supposed to be worn for 10 days so this causes significant discomfort.Fda safety report id# (b)(4).

• Brand Name: G6 CONTINUOUS GLUCOSE MONITOR SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10332113
• MDR Text Key: 200803979
• Report Number: MW5095744
• Device Sequence Number: 3
• 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: 07/23/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9500-45
• Device Lot Number: 5271496
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 109