TANDEM DIABETES CARE
Manufacturer adverse-event records for TANDEM DIABETES CARE 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 · 2014–2026 · heavy-book · quiet Death-code · balanced
Volume signature
TANDEM DIABETES CARE sits in the heavy MAUDE book
TANDEM DIABETES CARE accounts for 1,330,642 FDA MAUDE reports (#4 of 434, heavy-book tercile). Death-coded event_type share is 0.02% (quiet); Injury share 11.7% (balanced).
What the volume reading shows for TANDEM DIABETES CARE
The standout signal for TANDEM DIABETES CARE is filing volume: 1,330,642 adverse-event reports in FDA MAUDE (#4 of 434, heavy-book). Death-coded event_type share sits at 0.02% (quiet).
As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair TANDEM DIABETES CARE 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 7 device types, led in this extract by Malfunction at 1,174,836 (88.3% of event_type total). Peak single-year volume reaches 253,456 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 (7)
Yearly Trend
Read our methodology - how this data is sourced, computed, and verified.