MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG

Model Number G6

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

Patient Problems Erythema (1840); Rash (2033); Skin Tears (2516)

Event Date 04/15/2022

Event Type  Injury  

Event Description

Started using dexcom g6 continuous glucose monitor and experiencing significant harm to my skin where the sensor is placed.I do not have sensitive skin or any known skin related issues.After using the g6 sensor, skin becomes red, rashes starts to appear and then become peeling off.Adhesive used in dexcom g6 is very bad.There are lots of reported similar issues in the internet and an existing complaint to fda on the same problem.Is there a solution arrived for this problem? why is this product continues to be prescribed with such severe side effects.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM FOR NON-INTENSIVE DIABETES MANAG
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 14160972
• MDR Text Key: 289752403
• Report Number: MW5109166
• Device Sequence Number: 1
• Product Code: QDK
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: G6
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: INSULIN
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian