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

Device Problems Material Protrusion/Extrusion (2979); Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2021

Event Type  malfunction  

Event Description

This is the 10th time that a dexcom g6 inserter has jammed and been stuck on my body.It takes blunt force to get the spring to release the sensor.This time was the first time that the sensor failed to release at all, but i was at least able to get the inserter off my body, with the sensor and needle still protruding.Dexcom seems to be aware of the problem, but silent about it.They don't even have it on their support form as an issue you can select about their sensor.Fda safety report id# (b)(4).

• Brand Name: SENSOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11343654
• MDR Text Key: 232822619
• Report Number: MW5099462
• Device Sequence Number: 2
• 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: 02/15/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 101