Diabetes Devices Dominate FDA MAUDE Reports 2020-2025 with Over 50% of Adverse Events, Dexcom Largest Single Reporter

June 20, 2026

Global MedTech Expert | 10× MedTech Global Access Unknown

Overview

An analysis of 14.4 million FDA MAUDE adverse event reports from 2020 to 2025 reveals that diabetes-related devices account for over half of all reported events. Continuous Glucose Monitoring (CGM) systems and insulin pumps are identified as primary devices, with Dexcom independently submitting the largest number of reports in 2025 at 353,869 events. This data underscores the critical ongoing importance of safety management alongside the widespread adoption of diabetes technology.

In Depth

Key Findings

A comprehensive analysis of the FDA’s MAUDE (Manufacturer and User Facility Device Experience) database has been released, indicating that diabetes-related devices were associated with over 50% of the total 14.4 million medical device adverse event reports filed between 2020 and 2025. Throughout this period, Continuous Glucose Monitoring (CGM) systems and insulin pumps emerged as the leading reporting device categories. Notably, Dexcom accounted for the highest number of individual adverse event reports in 2025, with 353,869 reported incidents.

Technical/Clinical Details

The MAUDE database serves as a vital repository for the FDA to collect information on suspected problems—adverse events—associated with medical device usage. These reports encompass device malfunctions, operational errors, improper use, or adverse impacts on patient health. The high volume of reports concerning diabetes devices, particularly CGMs and insulin pumps, reflects their widespread adoption and extensive use among patients. However, given the deep integration of these devices into patients’ daily lives, even minor issues can lead to frequent reporting. Dexcom’s position as the largest single reporter likely indicates both its substantial market share in the CGM sector and its diligent reporting mechanisms.

Background & Context

In diabetes management, CGMs and insulin pumps have significantly improved patients’ quality of life and glucose control. Yet, with their expanding use, issues related to device safety and functionality also become more prominent. The FDA utilizes MAUDE data to identify potential risks associated with medical devices, prompt manufacturers for improvements, and, when necessary, issue recalls or safety advisories. These analysis findings emphasize the crucial need for ongoing safety surveillance and quality enhancements as diabetes device technology continues to advance and proliferate.

Strategic Significance & Outlook

These MAUDE data trends will likely compel diabetes device manufacturers to intensify efforts in enhancing product design safety, improving user interfaces, and ensuring comprehensive patient education on proper device use. For CGM systems specifically, continued improvements are anticipated in measurement accuracy, skin reactions at the sensor site, and the reliability of data transmission. Regulatory bodies may leverage such data to impose more stringent post-market surveillance requirements or to elevate safety evaluation criteria in new approval processes. This proactive approach aims to ensure that diabetes patients have access to increasingly safe and effective device technologies.

Source: https://meddeviceguide.com/blog/fda-maude-adverse-event-medical-device-safety-trends-analysis-2026

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