Instrument, Coagulation, Automated

What the Data Shows About Instrument, Coagulation, Automated

The FDA MAUDE database aggregates 660 adverse-event reports for Instrument, Coagulation, Automated spanning the period from 1994 through 2024. Of these, 13 are classified as death reports, 70 as injury reports, and 530 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 5 distinct event types and 10 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 18 distinct product-problem codes appear in the reports, with Incorrect, Inadequate or Imprecise Result or Readings topping the list at 34 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 31 years of MAUDE data, with the peak single-year volume reaching 190 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 8 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.