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

Model Number G6

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 09/16/2020

Event Type  Injury  

Event Description

My daughter uses dexcom g6 cgm which is a self-insertion glucose monitor.You push the button and it inserts in your skin.The needle then retracts and the sensor releases from the insertion device leaving the sensor on the body.This is the second time in a month we've had the problem that the needle doesn't retract and the sensor doesn't release.The whole contraption remains on her arm, and she has to pull the adhesive off and get it off her arm.This time when she pulled it off, the needle was bent.And it was sticking out.I did not report the previous time, which happened about two weeks ago.Fda safety report id# (b)(4).

• Brand Name: DEXCOM CGM G6
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 10573665
• MDR Text Key: 208359432
• Report Number: MW5096811
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/28/2021
• Device Model Number: G6
• Device Lot Number: 5278429
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 57