ROCHE DIABETES CARE, INC.
Manufacturer adverse-event records for ROCHE DIABETES CARE, INC. 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 · 2013–2026 · heavy-book · quiet Death-code · injury-light
Volume signature
ROCHE DIABETES CARE, INC. sits in the heavy MAUDE book
ROCHE DIABETES CARE, INC. accounts for 50,721 FDA MAUDE reports (#76 of 434, heavy-book tercile). Death-coded event_type share is 0.01% (quiet); Injury share 5.5% (injury-light).
What the volume reading shows for ROCHE DIABETES CARE, INC.
The standout signal for ROCHE DIABETES CARE, INC. is filing volume: 50,721 adverse-event reports in FDA MAUDE (#76 of 434, heavy-book). Death-coded event_type share sits at 0.01% (quiet).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ROCHE DIABETES CARE, INC. 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 16 device types, led in this extract by Malfunction at 47,907 (94.5% of event_type total). Peak single-year volume reaches 8,125 reports across 13 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 (16)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.