System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

What the Data Shows About System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

The FDA MAUDE database aggregates 431 adverse-event reports for System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates spanning the period from 2015 through 2021. Of these, 0 are classified as death reports, 10 as injury reports, and 420 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 4 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 14 distinct product-problem codes appear in the reports, with Incorrect, Inadequate or Imprecise Result or Readings topping the list at 272 reports. Reports are associated with 7 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 7 years of MAUDE data, with the peak single-year volume reaching 107 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 2 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.