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

Device Problem Product Quality Problem (1506)

Patient Problems Rash (2033); Skin Irritation (2076); Reaction (2414)

Event Date 08/29/2020

Event Type  Injury  

Event Description

I am a type 1 diabetic and i use a dexcom g6.The last sensor had some issues and i thought it was a fluke but when i switch to a new sensor i had the same issues.My skin broke out into a very irritated rash.It is excruciatingly irritated.Dexcom never warned me that they were using a new adhesive.I have never in my life had a negative reaction to any adhesive and i do not have sensitive skin at all.Diabetics are prone to infection and complications involved in healing.I am left with blisters.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10482392
• MDR Text Key: 205495984
• Report Number: MW5096373
• 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: 08/29/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• 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: 37 YR
• Patient Weight: 58