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

Model Number 9500-45

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Caustic/Chemical Burns (2549)

Event Date 07/16/2020

Event Type  Injury  

Event Description

This issue has been occurring since the beginning of 2020.I use a dexcom g6 to help monitor my blood glucose since i am a type 1 diabetic.The adhesive is giving me a chemical burn/ rash.The device is suppose to stay on for 10 days, but due to the adhesive eating my skin, it falls off in less than a week.The spot where the device was takes multiple weeks to fully heal.I have used dexcom for years and never had this issue until this year.I also wear an omnipod and don't have the adverse reaction i do to the dexcom g6 sensor adhesive.While the device gives me better control of my diabetes, i am not the benefits outweigh the pain experience.Fda safety report id # (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10307482
• MDR Text Key: 200201111
• Report Number: MW5095644
• 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: 07/17/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9500-45
• Device Catalogue Number: STS-OR-003
• Device Lot Number: 5271469
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 80