PlainHospital

ANIMAS LLC

Manufacturer adverse-event records for ANIMAS LLC 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 · 2018–2020 · mid-book · quiet Death-code · injury-light

Injury-mix signature

ANIMAS LLC is lighter on Injury codes

Injury-coded event_type share is 3.3% (injury-light tercile) beside 0.03% Death-coded (quiet). Volume band: mid.

What the Injury-mix reading shows for ANIMAS LLC

The standout signal for ANIMAS LLC is Injury-mix: 3.3% Injury-coded (injury-light) beside 0.03% Death-coded, on a mid-book footprint.

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

Reports span 8 device types, led in this extract by Malfunction at 16,141 (96.7% of event_type total). Peak single-year volume reaches 10,538 reports across 3 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

16,695
Total Reports
5
Event-type Death
549
Injury Reports
8
Device Types

Event Types

Malfunction 16,141 (96.7%)
Injury 549 (3.3%)
Death 5 (0.0%)

Patient Outcomes

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

16,155 (94.8%)
Life Threatening 398 (2.3%)
R 209 (1.2%)
Hospitalization 136 (0.8%)
L 135 (0.8%)
Death 4 (0.0%)
H 1 (0.0%)
Required Intervention 1 (0.0%)

Devices (8)

Device Reports
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor 13,751
Pump, Infusion, Insulin 2,922
Sensor, Glucose, Invasive 17
Endoscopic Guidewire, Gastroenterology-Urology 1
Patient Bed With Canopy/Restraints 1
Post Breast Biopsy Hemostatic Breast Compression Device 1
Pump, Infusion 1
Set, Administration, Intravascular 1

Yearly Trend

18
2018: 10,538
19
2019: 5,932
20
2020: 225

Read our methodology - how this data is sourced, computed, and verified.