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

Lot Number 5277085

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rash (2033); Skin Irritation (2076); Discomfort (2330); Reaction (2414)

Event Type  Injury  

Event Description

Bad rash.I'm a dexom user for approximately 4 years and last year when i tried to place dexom sensor i felt like a burn on my skin after 1 hour or so.It was very uncomfortable and after 2-3 days i removed it and i had a very bad skin reaction.I contacted dexom and i was advised to use a skin barrier which i still do.I also explained to them that i'm a long-time user and i never had a skin reaction before and it started now, they said that dexom did some changes on the adhesive formula and maybe that's why it happen.I'm still using the product just i do purchase skin barriers and use it that way.Fda safety report id # (b)(4).

• Brand Name: DEXOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM INC.
• MDR Report Key: 11272724
• MDR Text Key: 230475119
• Report Number: MW5099177
• Device Sequence Number: 1
• 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: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/07/2021
• Device Lot Number: 5277085
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR