MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM G6 ; SENSOR, GLUCOSE, INVASIVE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Skin Inflammation (2443)

Event Date 05/01/2020

Event Type  Injury  

Event Description

I use the dexcom g6 sensor.Dexcom made a change to their adhesive formula end of 2019.When using the new sensors, i break out in terrible, painful rashes.I can't wear the patch the full 10 days through.My skin becomes highly inflamed and takes approx 6-8 weeks to heal.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10162836
• MDR Text Key: 195701964
• Report Number: MW5095030
• 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: 06/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 70