The Dexcom G6 (Dexcom Inc.) is a continuous glucose monitoring (CGM) system that measures glucose levels in real-time throughout the day and night. It is a small, wearable device placed on the skin and uses a tiny sensor to measure glucose levels. The Dexcom G6 system provides users with real-time glucose readings, high and low glucose levels alerts, and trend information to help manage their diabetes.
The sensors connect to a transmitter with blue tooth technology, which wirelessly connects to an application downloaded on a user’s phone. The phone app displays the user’s blood sugar level and is updated every five minutes.
Since the Food and Drug Administration authorized the sale of the G6 in 2018, the agency has have received 500,000 Maude Device Reports of product defects,13 of which are linked to deaths. Dexcom Inc. markets its device as a convenient alternative to manual monitoring, assuring users that it will alert them with an alarm in case of low or high blood sugar levels, or any app malfunctions. However, the majority of the half a million FDA complaints, the device failed to notify the users of potentially life-threatening low or high blood glucose levels, resulting in injuries and fatalities.
In 2016, Dr. Alan Shapiro of the American Medical Association published an article titled “FDA Approval of Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing A Potentially Risky Decision”. The article highlighted issues with a previous Dexcom’s previous model, the G5, which prompted at least 65,000 reports of inaccurate blood glucose readings between October 2016 and June 2017. As a part of the approval process for the device, the FDA panel should have been provided with this data before making their decision; however, it was not provided. Despite Dr. Shapiro repeated attempts reach the FDA to express his concerns, he did not receive a response. The FDA moved forward of authorization of the G5 three months later.
In a 2019 MDR, a consumer stated that “the sensors are apt to fail at least 25% of the time or higher.” Since then, there have been three separate recalls related to Dexcom’s product issues. These include the low alarm feature on the iOS application failing to alert users, shipping delays leading to exposure to temperature fluctuations that caused inaccurate results, and potential interference from hydroxyurea resulting in falsely elevated glucose readings.
The FDA does not consider the half-million reports associated with Dexcom’s G6 to be a significant number nor places much weight on the three recalls in the past few years. Furthermore, it does not have a predefined threshold for the number of complaints required to initiate action against a device. Thus, Dexcom’s G6 remains on the market, putting countless unsuspecting users at risk.