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

Lot Number 5268609

Device Problem Product Quality Problem (1506)

Patient Problems Rash (2033); Swelling (2091); Reaction (2414)

Event Date 06/17/2020

Event Type  malfunction  

Event Description

I use the dexcom 6 cgm.The past two sensors i have had a horrible reaction to the adhesive causing a rash and blisters.I have used the cgm for 3 years with no previous problems.Fda safety report id# (b)(4).

• Brand Name: G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10179305
• MDR Text Key: 196200709
• Report Number: MW5095119
• 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: 06/17/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/14/2021
• Device Lot Number: 5268609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 73