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

Model Number G6

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

Patient Problems Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 10/12/2020

Event Type  Injury  

Event Description

Skin burn; extreme skin irritation/chemical burn from dexcom g6 glucose monitor.I was supposed to leave on for 10 days but had to remove after 7 because of extreme irritation.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 GLUCOSE SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10684433
• MDR Text Key: 211714017
• Report Number: MW5097243
• Device Sequence Number: 1
• Product Code: MDS
• UDI-Device Identifier: 00386270000255
• UDI-Public: (01)00386270000255
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/08/2021
• Device Model Number: G6
• Device Catalogue Number: 9500-45
• Device Lot Number: 7277593
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Weight: 94