Class Action Case Alleges Dexcom Continuous Glucose Monitors Are ‘Adulterated,’ Sold Illegally

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The maker of Dexcom G6 and G7 continuous glucose monitors faces a proposed class action lawsuit after receiving a Food and Drug Administration warning letter about an unapproved change in the material used to make the devices’ sensors. 

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The 23-page class action lawsuit against Dexcom, Inc. says that the change in materials to the G6 and G7 sensors caused them to have “considerably greater variability” than readings from sensors made with the previous FDA-approved material, causing higher risks for consumers who used the newer sensors. 

Per the case, the G6 and G7 continuous glucose monitoring (CGM) products—advertised as effective at monitoring a user’s blood glucose levels in real time, without fingersticking or scanning, to warn if levels are too high or too low—were cleared by the FDA in March 2018 and December 2022, respectively.

According to the lawsuit, however, in March 2025, after an inspection of the company’s San Diego and Mesa, Arizona facilities, Dexcom received an FDA warning letter in which the agency contended that the glucose monitoring devices at issue were adulterated and misbranded due to certain “major changes or modifications” made without the submission of a new premarket notification as required by law. 

Per the complaint, the FDA said that Dexcom modified the critical G6 and G7 CGM sensors by replacing one of the materials used to make the sensors with a different one that the defendant claimed was equivalent to the former, i.e., the material used in the clinical studies submitted for the devices’ FDA approval. However, the FDA noted that the company’s own studies showed that the sensors made with the newer material performed worse, causing greater testing inaccuracies and consequently higher risks for patients who rely on the devices for diabetes treatment, the lawsuit relays. 

The suit contends that consumers who have purchased the Dexcom G6 and G7 CGMs have not received the benefit of their bargain and were misled into buying products whose quality and performance were inferior to what was advertised.

“The Products are not as valuable as the prices Plaintiffs and Class members paid for them,” the filing argues.

The plaintiffs, Santa Clara County and Riverside County, California residents, claim to have experienced “incorrect readings” from the Dexcom G6 and G7 devices and sensors in comparison to manually taken blood sugar readings.

The Dexcom class action lawsuit looks to cover all United States residents, including those of the District of Columbia, Puerto Rico and the U.S. Virgin Islands, who, within the applicable statute of limitations period, bought a Dexcom G6 and/or G7 continuous glucose monitoring device and/or sensor that was made using sensor materials different from that approved by the FDA.

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