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

Device Problem Defective Alarm (1014)

Patient Problem Hypoglycemia (1912)

Event Date 08/06/2021

Event Type  Injury  

Event Description

This has happened multiple times in the past 3 months.I have insulin dependent diabetes and wear a dexcom g6 sensor to track my blood sugars.I rely on this to alert me when my blood sugar goes low, but lately it has not been alerting me/missing alerts.This is life threatening as i have slept through multiple low blood sugars and my blood sugar has dropped below 55mg/dl into the urgent low category.It is generally only then that i get the alert, despite the fact that i have low alerts on starting at 70, and have it set to repeat every 15 minutes.It is extremely inconsistent about repeating this alert, or even alerting me in the first place when i go low.I have screenshots of my graphs with this happening on (b)(6) 2021.I have gone urgently low in my sleep and there are missing alerts.This is dangerous and dexcom needs to fix this.Fda safety report id# (b)(4).

• Brand Name: DEXCOM G6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 12432725
• MDR Text Key: 270306153
• Report Number: MW5103737
• Device Sequence Number: 1
• Product Code: MDS
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 25 YR