TANDEM DIABETES CARE INC.

Manufacturer adverse-event records for TANDEM 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 · 2013–2025 · mid-book · typical Death-code · balanced

Death-code intensity

TANDEM DIABETES CARE INC. tracks a typical Death-code share

Death-coded event_type rows are 13 of 12,985 (0.10% · typical tercile among 443 manufacturers). Absolute volume is mid-book.

What the Death-code reading shows for TANDEM DIABETES CARE INC.

The standout signal for TANDEM DIABETES CARE INC. is Death-code intensity: 0.10% of 12,985 reports (typical tercile), while absolute volume is mid-book.

Mid-pack volume still shows a clear device fingerprint; the table below is the actionable layer for TANDEM DIABETES CARE INC.. Event_type Death/Injury codes differ from patient-outcome rows - see methodology.

Reports span 6 device types, led in this extract by Malfunction at 8,558 (65.9% of event_type total). Peak single-year volume reaches 8,205 reports across 10 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

12,985
Total Reports
13
Event-type Death
4,409
Injury Reports
6
Device Types

Event Types

Malfunction 8,558 (65.9%)
Injury 4,409 (34.0%)
Death 13 (0.1%)
3 (0.0%)
Other 2 (0.0%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

8,587 (64.1%)
Other 3,819 (28.5%)
Hospitalization 427 (3.2%)
R 396 (3.0%)
Required Intervention 133 (1.0%)
Death 15 (0.1%)
O 13 (0.1%)
L 4 (0.0%)
Disability 2 (0.0%)
Life Threatening 2 (0.0%)
H 1 (0.0%)
S 1 (0.0%)

Yearly Trend

13
2013: 7
14
2014: 4,755
15
2015: 8,205
16
2016: 2
18
2018: 1
19
2019: 1
20
2020: 1
21
2021: 1
24
2024: 9
25
2025: 3