Hunterbrook Media released a short report on diabetes-focused DexCom Inc. (NASDAQ:DXCM), citing that the company sold the "adulterated" device.
Benzinga reached out to DexCom for comments and is yet to hear from them.
A surprise FDA inspection found Dexcom made an unauthorized design change to the G7 glucose monitoring device, with internal tests showing worse accuracy across the board.
Despite this, the company sold the device, drawing FDA scrutiny. Executives have since departed as patient complaints climbed, rivals gained share, insiders sold stock, and accounting practices came under question.
Also Read: Goldman Sachs Bullish On Dexcom And Insulet As Diabetes Tech Surges
Many patients are reverting to the G6 or shifting to competitors, suggesting Dexcom's challenges run deeper than expected.
Reports collected by Hunterbrook include accounts of patients suffering severe consequences from inaccurate G7 readings.
A law firm investigating the device said at least 60 people have been hospitalized, with multiple deaths alleged. A Facebook group dedicated to G7 issues surged past 58,000 members in little over a year.
Former employees describe a culture that placed profits above patient safety.
Some said the G7 was rushed to market to compete with Abbott Laboratories (NYSE:ABT).
The short report alleges the leadership of the team behind a component flagged by the FDA reportedly lacked the proper expertise.
The report added that one former senior director of manufacturing admitted, "Dexcom definitely dropped the ball," and "the arrogance of Dexcom is really what needed to be reset.”
Others claimed the company compromised safety to protect profit margins.
Endocrinologists interviewed noted higher-than-usual sensor inaccuracies, frequent device failures, and adhesive problems. Several said they no longer prescribe the G7, and some described Dexcom's responses to complaints as dismissive or misleading.
Internal documents show that in December 2023, Dexcom altered a critical sensor coating without regulatory clearance. FDA inspectors later cited the company for selling "adulterated" devices after its own studies showed accuracy issues. Complaints spiked after the material switch, according to Hunterbrook's analysis of FDA data.
Despite marketing the G7 as the "most accurate CGM," including in a 2023 Super Bowl ad featuring Nick Jonas, Dexcom has received more FDA accuracy complaints than Abbott's competing Libre 3.
Financially, Dexcom has come under scrutiny for accounting tactics that boosted recent earnings. Citing analysts, the report warns the company could face another downside surprise similar to 2024, when disappointing results triggered a sharp stock decline.
Meanwhile, Dexcom has been hit by executive departures, including the abrupt exit of longtime CEO Kevin Sayer, and growing competitive threats from Abbott and the rise of GLP-1 drugs that could slow diabetes growth rates.
DXCM Price Action: DexCom shares were down 4.54% at $72.97 at the time of publication on Thursday. The stock is trading within its 52-week range of $57.52 to $93.25, according to Benzinga Pro data.
Read Next:
Photo: Photo Nature Travel / Shutterstock.com
© 2025 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
