ROCHE DIAGNOSTICS CORP.
Manufacturer adverse-event records for ROCHE DIAGNOSTICS CORP. 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 · 1999–2018 · thin-book · typical Death-code · balanced
Volume signature
ROCHE DIAGNOSTICS CORP. is a thinner MAUDE footprint
ROCHE DIAGNOSTICS CORP. accounts for 3,581 FDA MAUDE reports (#439 of 443, thin-book tercile). Death-coded event_type share is 0.31% (typical); Injury share 29.5% (balanced).
What the volume reading shows for ROCHE DIAGNOSTICS CORP.
The standout signal for ROCHE DIAGNOSTICS CORP. is filing volume: 3,581 adverse-event reports in FDA MAUDE (#439 of 443, thin-book). Death-coded event_type share sits at 0.31% (typical).
As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.
Reports span 20 device types, led in this extract by Malfunction at 2,499 (69.8% of event_type total). Peak single-year volume reaches 821 reports across 16 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.