Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

What the Data Shows About Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management

The FDA MAUDE database aggregates 620 adverse-event reports for Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management spanning the period from 2018 through 2025. Of these, 1 is classified as a death report, 18 as injury reports, and 601 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe, widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 3 distinct event types and 11 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Wireless Communication Problem topping the list at 385 reports. Reports are associated with 5 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 8 years of MAUDE data, with the peak single-year volume reaching 238 reports - trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 3 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice, discuss device-safety questions with your healthcare provider.