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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Reaction (2414)

Event Date 06/01/2020

Event Type  Injury  

Event Description

I use the dexcom 6 glucose device and the sensor that i attach to my skin breaks it out severely.I started using this product in (b)(6) 2020 and did not any issues.It came with a 3 month supply, but when i reordered that is when i started having the problem.I have notified dexcom about the problem.They have called me buy that does not help with my skin breaking out.I have done research on the inter net i notice other people having the same problems.They call it the dexcom rash.I have tried barrier tape, barrier wipes, spraying flonase on the spot where i attach the dexcom sensor.The concept is good but it has to be something that can be done for us people that break out.I saw a internet post that said that i should contact the fda and tell them about my problem.I do not know what you can do, but i wanted to make you aware of what is happening with the dexcom 6 sensors.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11332486
• MDR Text Key: 232220688
• Report Number: MW5099392
• Device Sequence Number: 2
• Product Code: MDS
• 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: 02/11/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 66 YR
• Patient Weight: 120