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Short Report Alleges Dexcom Sold Faulty G7 Device Cited By FDA
Benzingaยท 2025-09-18 14:57
Core Insights - Hunterbrook Media released a report alleging that DexCom Inc. sold an "adulterated" glucose monitoring device, the G7, which underwent unauthorized design changes leading to accuracy issues [1][6] - The company has faced increased scrutiny from the FDA, executive departures, and a rise in patient complaints, indicating deeper challenges within DexCom [2][8] Group 1: Product Issues - A surprise FDA inspection revealed that DexCom made unauthorized changes to the G7 device, resulting in worse accuracy [1][6] - Reports indicate that many patients are reverting to the older G6 model or switching to competitors due to severe consequences from inaccurate G7 readings [3][4] - Internal documents show that DexCom altered a critical sensor coating without regulatory clearance, leading to a spike in complaints [6] Group 2: Financial and Market Impact - DexCom has been scrutinized for accounting practices that artificially boosted earnings, raising concerns about potential future financial surprises [7] - The company's stock price fell by 4.54% to $72.97, trading within a 52-week range of $57.52 to $93.25 [8] Group 3: Leadership and Culture - Executive departures, including the sudden exit of CEO Kevin Sayer, have compounded the company's challenges [8] - Former employees have described a corporate culture that prioritized profits over patient safety, with claims that the G7 was rushed to market [4][5]