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

Catalog Number PN: 9500-45

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

Patient Problems Pain (1994); Scar Tissue (2060)

Event Date 02/18/2021

Event Type  Injury  

Event Description

Bodily injury; this device's applicator is intended to insert a sensor thread into the body, by inserting and immediately retracting a needle, and releasing the sensor from the applicator and attaching sensor to body.During this malfunction, the needle did not retract, and the applicator did not release its sensor.To remove sensor and applicator from my body, i ripped sensor from my body while holding the applicator.This caused needle to tear out of my body, which resulted in much pain and physical scars.Two similar incidents occurred on (b)(6) 2019, which was reported to your office on form 3500b (access number mw5091501), and on (b)(6) 2021, which was also reported to your office on form 3500b (access number not yet provided to me).I began using dexcom's g6 about two years ago.Based on four incidents on (b)(6) 2019, (b)(6) 2021, and two on (b)(6) 2021, i do not consider this device safe.Each device is intended for a lifespan of 10 days of use.However, in recent years its quality has deteriorated.Most sensors do not function reliably between the seven and 10 day lifespan.I do not consider this device effective after seven days of use.Dexcom (manufacture) did not recall the lot numbers, and was unwilling to issue a product recall when i contacted them.I have experienced four product malfunctions - two on the sale day.When will the fda require a product recall?.Fda safety report id # (b)(4).

• Brand Name: DEXCOM G6 SENSOR & APPLICATOR
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 11776406
• MDR Text Key: 249730417
• Report Number: MW5101148
• Device Sequence Number: 3
• 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: 04/30/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/06/2021
• Device Catalogue Number: PN: 9500-45
• Device Lot Number: 7280520
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR