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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Scar Tissue (2060); Blister (4537)

Event Date 03/18/2020

Event Type  Injury  

Event Description

For over a year i used the dexcom g6 continuous glucose monitor.It caused horrible blistering rashes and scars.These would begin about 24 hours after applying the sensor and remain and worsen until removed.I reported this problem to dexcom and they did not help.My doctor and i joined (b)(6) forums to try to find solutions like allergy sprays and barriers to put underneath but nothing worked.I have a horrible scars on my legs abdomen and arms.I have discontinued use.I now use the freestyle libre sensor and have no rashes.I also use the omnipod insulin pump and get no rashes from their adhesives.Something seems to be very off and harmful about the dexcom adhesive.

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11561793
• MDR Text Key: 242265345
• Report Number: MW5100208
• Device Sequence Number: 2
• Product Code: MDS
• Combination Product (y/n): Y
• 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: 03/21/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 36 YR
• Patient Weight: 67