Pump, Infusion, Insulin
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.5725 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Pump, Infusion, Insulin HEAVY-BOOK · MAUDE
#7 of 1000 · 539,077 reports · 1992–2026
- BOOK 539,077 reports
- RANK #7 of 1000
- DEATH 1,411 death-typed
- INJ 96,050 injury-typed
- MALF 439,826 malfunction
- SPAN 1992–2026
- PEAK 2015: 69,136
- PHOTO Automated Insulin Dos…
Nearest event-volume peer: Automated Insulin Dosing , Threshold Suspend (99,679 report gap)
Pump, Infusion, Insulin sits #7 of 1000 among tracked device types with 539,077 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports run above the device-type norm
Pump, Infusion, Insulin carries 81.6% MALFUNCTION-coded reports, 16.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 17.8% corpus 30.3% · below corpus mean (-12.5 pp)
- MALF 81.6% corpus 64.8% · above corpus mean (+16.8 pp)
Lead product-problem code Unintended Movement is 10% of coded problems · Lead manufacturer ANIMAS CORPORATION accounts for 31% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .
Pump, Infusion, Insulin in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Pump (this)
Pump, Infusion, Insulin
539,077 reports
- Automated Ins…
Automated Insulin Dosing , Threshold Suspend
439,398 reports
- System
System, Test, Blood Glucose, Over The Counter
431,358 reports
- Implantable C…
Implantable Cardioverter Defibrillator (Non-Crt)
379,353 reports
- Stimulator
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
375,710 reports
- Permanent Pac…
Permanent Pacemaker Electrode
325,343 reports
What this shows Pump, Infusion, Insulin carries 539,077 MAUDE reports, ranked #7 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports fell to 12,151 in 2025, down from an average of 20,100 in the two years before.
Related Entities for Pump, Infusion, Insulin
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pump, Infusion, Insulin: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (539,077 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,411 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pump, Infusion, Insulin are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Pump, Infusion, Insulin; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.