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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Skin Discoloration (2074)

Event Type  Injury  

Event Description

Symptoms: bruising, suspect drug# 1, dosing: 1 every 10 days.Veteran is type 1 and using the dexcom g6 continuous glucose monitoring system she has used this system for some time without problem, "i had my first bad reaction with my last sensor, it has left a very large black/blue spot,'' he states this occurred approximately 10 days ago (approx (b)(6) 2020) after she removed the dexcom sensor from her abdomen.Dates of use: approx (b)(6) 2018 - na.Reason for use: diabetes mellitus.

• Brand Name: GLUCOSE SENSOR (GLUCOSE SENSOR DEXCOM G6)
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10288767
• MDR Text Key: 199457906
• Report Number: MW5095561
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR