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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Skin Irritation (2076)

Event Date 05/29/2020

Event Type  Injury  

Event Description

For the third application in a row, dexcom sensor adhesive has resulted in a rash.It doesn't hurt or itch, but when i remove the sensor at the end of its 10-day life the rash is obvious.I have raised red bumps and some flat red scaly areas.The rashes from the first two sensors look like they may leave scars; 20 days and 10 days after removal the red bumps are still visible.The three sensors came from two different boxes.I have never had an adhesive rash before these last three and have always applied sensors in a rotation on my upper abdomen, cleaned well with alcohol before application.I notified dexcom via chat today and they took a report.Attached file shows the rash beneath the sensor i removed today; below the rash is a new sensor for scale.Fda safety report id# (b)(4).

• Brand Name: DEXCOM SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10114244
• MDR Text Key: 194042826
• Report Number: MW5094804
• Device Sequence Number: 2
• 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: 05/29/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• 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 Age: 48 YR
• Patient Weight: 82