MAUDE Adverse Event Report: DEXCOM, INC. DEXCOM CGM G6; INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM

Model Number DEXCOM G6

Device Problems Defective Component (2292); High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 11/30/2018

Event Type  Injury  

Event Description

A perpetual ¿backorder ¿ of dexcom g6 continous glucose sensors have stranded many with a discontinuation of therapy.I (as well as many others) have had a discontinuation or interruption of therapy in the management of our diabetes because of dexcom¿s continual acceptance of new patients while they are unable to provide therapy and support to their already existing patients.I am a type 1 diabetic since the age of 10.I was pleased to see that the fda (to my understanding) streamlined the approval of the g6 cgm from dexcom.But, what good is a product that works with tandem insulin pumps that stops therapy, starts therapy, adjusts therapy whereas the dexcom g6 cannot be supplied? shouldn't the sanctity of human life be preserved with fda mandating a stop of accepting new patients on behalf of dexcom until they can meet the needs of already existing patients.This lack of a continuity of care forces those who have established new basals for insulin therapy, new correction factors for meals, etc to alter their therapy or permit their blood glucose to run at higher level until they can reestablish new basals and correction factors until their ordered products are made available.The fda may want to investigate the fact that many have begun to utilize their dexcom cgm sensors by ¿tricking¿ them to be used beyond their use date because of perpetual backlogs of supply (i just discovered this on (b)(6)).What seems odd is the chastising by the population of the fda about approval process where it is my understanding that the fda has opened up new pathways for the approvals of the continuous glucose products and insulin pumps but has only resulted in those suppliers in not being able to maintain their supplies to patients.Further, when a sensor fails, both companies play a literal ¿kick ball game ¿ with their patients.If a dexcom sensor fails as they often do - a patient is directed to call tandem insulin pumps if they are utilizing an insulin pump.When the patient then calls tandem, they are instructed to call dexcom or given a difficult time about the failure of the product.It should be further noted that patients are only given an allocation of medication per insurance - so, this of course leads people to circumvent good healthcare practices by ¿tricking¿ their products to be used outside of fda approved guidelines.This ¿kickball¿ game has happened to me multiple times last friday being the most recent occurrence.And as a result ¿ the replacement ¿sensor¿ is on backorder and shipping is delayed.One has to question the larger impact of permitting increased blood sugars and the long term ramifications of being forced to do so.Wouldn't the increase in a1cs increase complications? sadly, this financial impact will hit the entire nation with our current healthcare system.Dates of use: (b)(6) 2018 - (b)(6) 2018; diagnosis or reason for use: type 1 diabetes (insulin dependent); is the product compounded? no.Is the product over-the -counter? no.

• Brand Name: DEXCOM CGM G6
• Type of Device: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): DEXCOM, INC.
• MDR Report Key: 8146779
• MDR Text Key: 130317753
• Report Number: MW5081971
• Device Sequence Number: 1
• Product Code: QDK
• 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
• Type of Report: Initial
• Report Date: 12/06/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/06/2018
• Device Model Number: DEXCOM G6
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 73