MAUDE Adverse Event Report: DEXCOM, INC. DEXCOMG6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED

Model Number G6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Rash (2033); Skin Irritation (2076)

Event Date 01/15/2020

Event Type  Injury  

Event Description

I have been using dexcom g6 sensor from around (b)(6) 2019 without any skin irritation or infection.Since dexcom has changed the sensor adhesive around (b)(6) 2019, i started experiencing severe skin rash and infection.I have contacted dexcom multiple times for alternate solutions and they weren't of any use and very reluctant to listen to the product problem.So far i have not received any updates from them.Fda safety report id# (b)(4).

• Brand Name: DEXCOMG6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10465378
• MDR Text Key: 204977858
• Report Number: MW5096316
• Device Sequence Number: 1
• Product Code: MDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• 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: 527 4677
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 47 YR