ROCHE DIAGNOSTICS
Manufacturer adverse-event records for ROCHE DIAGNOSTICS come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.
FDA MAUDE device safety record · 1997–2026 · heavy-book · quiet Death-code · injury-light
Volume signature
ROCHE DIAGNOSTICS sits in the heavy MAUDE book
ROCHE DIAGNOSTICS accounts for 126,401 FDA MAUDE reports (#26 of 434, heavy-book tercile). Death-coded event_type share is 0.06% (quiet); Injury share 5.9% (injury-light).
What the volume reading shows for ROCHE DIAGNOSTICS
The standout signal for ROCHE DIAGNOSTICS is filing volume: 126,401 adverse-event reports in FDA MAUDE (#26 of 434, heavy-book). Death-coded event_type share sits at 0.06% (quiet).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ROCHE DIAGNOSTICS with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.
Reports span 20 device types, led in this extract by Malfunction at 118,851 (94.0% of event_type total). Peak single-year volume reaches 10,486 reports across 30 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Devices (20)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.