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

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Scarring (2061); Skin Irritation (2076)

Event Date 06/25/2020

Event Type  Injury  

Event Description

Dexcom g6 continuous glucose monitor sensors caused skin irritation, rash and possible scarring due to what seems to be a reaction to their new stronger adhesive formula.I have red blistered patches where the last four sensors were located, most recently on my arm where i was forced to remove it early due to itching and pain.Patches of irritation on my abdomen from the last six weeks have not healed.Like many, many other users i had no problem with the old formulation, and apparently the company changed their adhesive early this year without warning, and thousands of users around the world are having similar and worse reactions.Patient is an athlete and in excellent health.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CONTINUOUS GLUCOSE MONITOR SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10223905
• MDR Text Key: 197596326
• Report Number: MW5095334
• Device Sequence Number: 4
• 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: 06/29/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G6
• Device Lot Number: 5271313
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 88