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

Lot Number 5243699

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 10/15/2018

Event Type  malfunction  

Event Description

We recently switched my (b)(6) from dexcom g5 to the dexcom g6.Since switching to the dexcom g6 in (b)(6) 2018 we have had 4/6 sensors malfunction requiring early removal.The sensors are stating that a "sensor cannot be restarted" even though it is a brand new sensor.When calling dexcom customer help their instructions chance depending on what agent you talk to.The first time we called on (b)(6) 2018 we were told we had to wait 2 minutes after the session end before starting a new session.On (b)(6) 2018 we had to replace two more sensors because we received the same message as above even though we were using a brand new sensor each time.We were told the sensors had to be removed and there was nothing to fix the problem.At the time we called the dexcom customer service we were told that the wait was not 2 minutes, but actually 5 minutes.On (b)(6) 2018 another newly placed sensor failed and stated the above message after waiting the 5 minutes between sessions as instructed.When contacting dexcom on (b)(6) 2018, we were informed that the wait was never 2 or 5 minutes between ending a session and starting a new sensor/session but it was 30 minutes.We were also told that we never needed to remove the sensors that failed because there is a "work around that makes it possible to restart a failed session".None of the literature nor patient pamphlets state that time must lapse before starting a new sensor.My child is hypoglycemic unaware and we heavily rely on a continuous glucose monitor to keep him safe and his glucose levels stable.Type 1 diabetes is life threatening if not managed.By switching to the dexcom g6 it has jeopardized my child's health because we go long lengths of time where no readings are available due to failed sensors.To compound the problem, the dexcom g6 is on rolling back orders so getting them replaced can take weeks.I ask that you please investigate dexcom as the faulty sensors are putting patient's lives at risk.The g6 should be as safe or safer than the g5.It clearly is not.Please hold dexcom accountable to finding proper resolutions that keeps their customers and patients safe by providing a safe and accurate continuous glucose monitor and accurate patient literature and instructions.

• Brand Name: DEXCOM G6 SENSOR
• Type of Device: SENSOR, GLUCOSE INVASIVE
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 7978741
• MDR Text Key: 124791027
• Report Number: MW5080627
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/16/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/25/2019
• Device Lot Number: 5243699
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Weight: 16