
The FDA’s MAUDE system received 13 reports of death associated with the Dexcom G6 between January 1, 2024, and September 30, 2024.
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People with diabetes have filed lawsuits over Dexcom G6 safety concerns.
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Continuous glucose monitors (CGMs) promise convenience for people with diabetes. But, more than half a million complaints have been filed with the U.S. Food and Drug Administration (FDA) regarding the Dexcom G6 CGM. Some patients are suing Dexcom, Inc. for defects in the G6 device that have led to at least 42 deaths. Learn more about Dexcom G6 lawsuits below.
What is the Dexcom G6?
Dexcom G6 is a continuous glucose monitor (CGMs) designed to help diabetic patients keep track of their blood sugar. CGMs can be used by any diabetic patient, no matter if they have Type 1, Type 2 or gestational diabetes.
CGMs are wearable devices. They differ from other glucose monitoring systems because they provide an on-demand readout of blood sugar and do not require patients to prick their fingers for data.
The Dexcom G6 has three main components:
Patients set up their blood glucose alerts on the receiver device. Alerts tell patients when their blood sugar is outside their set low or high levels. The Dexcom G6 also had an associated smartphone app for patients to use in place of their receiver.
Medical manufacturer Dexcom markets its CGMs as discreet and advanced systems capable of sending real-time readings to smart devices. Dexcom positioned the G6 to fully replace inconvenient fingersticks. It was the first FDA-approved integrated continuous glucose monitoring system.
While the device is often praised for its convenience, some question its safety. They allege the device took faulty readings and the phone app failed to alert patients of impending low blood sugar. If a patient misses these alerts, they could face dangerously low blood glucose, leading to coma, seizure or even death.
Dexcom G6 cases can be complicated. For many people, the G6 device works well and makes their lives easier. Motley Rice’s goal is not to take a beloved product off the market. Rather, our lawyers wish to help people who have been seriously harmed by the product through no fault of their own.
If the following criteria describes you or a loved one, you may be able to file a Dexom G6 lawsuit.
Keep in mind that patients who experienced hyperglycemia or who have a history of poorly controlled diabetes likely aren’t eligible to file a Dexcom G6 lawsuit. Read on to learn more about the defects with the Dexom G6 and its associated app, how many people have been harmed and how attorneys can help.
If you or a loved one suffered severe complications that you believe were caused by a Dexcom G6, our attorneys can discuss a potential claim. Complete this webform or call 1.800.768.4026 to contact attorney Jonathan Orent or Michael Pendell for more information.
In 2022 alone, medical researchers found that several top CGM brands had a total of 281,963 “adverse events.” This included 268,310 malfunctions. About 62% of the issues reported were faulty glucose readings. This was the Dexcom G6’s top adverse event.
The FDA’s reporting system for device malfunctions, Manufacturer and User Facility Device Experience (MAUDE), registers hundreds of thousands of reports concerning the Dexcom G6 CGM. This includes nearly 50 reported deaths.
“As a type 1 diabetic myself, I know firsthand how hard it can be to manage blood sugar. Significant strides in technology have been made over the years to help make our lives a little easier. But these advancements lose value if we can’t trust the tech to work as intended. When our technology fails, it puts our lives at risk,” said Motley Rice medical device attorney Jonathan Orent. “We believe Dexcom has led users to believe that their devices are foolproof, which makes patients completely reliant on the product. While the product is important, we believe the foolproof marketing concept is dangerously negligent and gives patients a false sense of security.”
The FDA received nearly 809,000 complaints about the G6 by 2022. Still more reports have been filed since then.
The issue with the Dexcom G6 largely centers around the IOS app installed on users’ phones. Lawsuits allege the app failed to warn users of low blood sugar, leading to serious hypoglycemic health impacts.
Here are a few examples of complaints from medical professionals and product users and their families, edited for usage and clarity:
You may have suffered severe health complications or lost a loved one. If so, a medical device attorney can help determine your options for seeking compensation. Civil litigation may also effectively compel medical manufacturers to improve their products.
People with diabetes rely on precise insulin measurements to adjust their blood sugar levels. If those measurements are wrong or users are not alerted to low blood sugar episodes, the results can be severe.
Short-term signs of low blood sugar include:
These symptoms could be a sign that a G6 device isn’t working properly.
Longer-term dangers of low blood sugar can include:
Dexcom maintains that its G6 is safe for use. No recall for the device has been issued, despite mounting reports of alleged malfunctions. However, the G6 iOS app was recalled in 2020. According to FDA documents, “the user’s low alarm feature on the iOS application [was] not properly alerting users when the user has enabled the Alert Schedule feature.” This means users who set up scheduled alerts for low blood sugar were not receiving them.
The IOS app was recalled under a Class 2 Device Recall. In this case, the “Class 2” refers to the category of the product, not the severity of the recall. The FDA has three device classes, determined “based on the level of control necessary to assure the safety and effectiveness of the device.”
Class 2, or Class II, devices do not require premarket approval and notification requirements. The FDA is far less involved in medical device approval than one might think.
Motley Rice Dexcom attorneys have extensive experience litigating claims related to faulty medical devices. They have the resources to act on your behalf, including:
09.01.24
The FDA’s MAUDE system received 13 reports of death associated with the Dexcom G6 between January 1, 2024, and September 30, 2024.
01.01.24
Dexcom launched a new version of the app that features loud, unignorable alerts when a patient’s blood sugar drops to dangerous levels.
12.31.23
MAUDE received 8 total reports of death associated with the Dexcom G6 in 2023.
12.31.22
MAUDE received 7 total reports of death associated with the Dexcom G6 in 2022.
12.31.21
MAUDE received 3 total reports of death associated with the Dexcom G6 in 2021.
10.28.21
News outlets covered the lawsuit of the wife of a Dexcom G6 user who died in Atlanta.
05.20.21
Judge Leigh Martin May dismissed the plaintiff’s claim for punitive damages against Dexcom. But the judge allowed the lawsuit to continue.
12.31.20
MAUDE received 6 total reports of death associated with the Dexcom G6 in 2020.
12.08.20
Consumer Reports covered what can be at stake when glucose reading devices don’t work properly.
03.02.20
The iOS app for the Dexcom G6 was recalled.
12.31.19
MAUDE received 5 total reports of death associated with the Dexcom G6 in 2019.
12.31.18
MAUDE received 2 total reports of death associated with the Dexcom G6 in 2018.
03.27.18
The FDA authorized Dexcom to begin marketing the Dexcom G6 integrated continuous glucose monitoring (iCGM) system.
Our attorneys have experience litigating for victims of defective medical drugs and devices, including diabetes products. We represent patients who allege their Medtronic insulin pumps delivered inaccurate doses. We have also litigated cases for clients involving:
Why are people filing Dexcom G6 lawsuits?
CGMs face technology glitches
Potential complications of Dexcom G6 CGM failure
How a medical attorney can help you with your Dexcom G6 lawsuit
Timeline of important updates about Dexcom lawsuits
Our diabetes litigation experience
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