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

Model Number G6

Device Problem Product Quality Problem (1506)

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

Event Date 08/18/2020

Event Type  malfunction  

Event Description

Dexcom g6 adhesive on sensor is causing rash/skin irritation due to the adhesive that keeps product in place.Dexcom has said that they changed the adhesive at the end of 2019.I noticed a packaging change the last time i filled the prescription, which dexcom told me likely indicates that i am now getting the "newer" sensors.This has happened twice, with the rash located directly under and shaped just like the adhesive (oval).Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10494164
• MDR Text Key: 205954370
• Report Number: MW5096440
• Device Sequence Number: 2
• Product Code: MDS
• 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: 09/02/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Lot Number: 7275258
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 139