Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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 MAUDE casebook
openFDA event book Pump HEAVY-BOOK · MAUDE
#5 of 1000 · 890,539 reports · 2004–2026
- BOOK 890,539 reports
- RANK #5 of 1000
- DEATH 2,249 death-typed
- INJ 126,552 injury-typed
- MALF 761,251 malfunction
- SPAN 2004–2026
- PEAK 2017: 132,643
- PHOTO Automated Insulin Dos…
Nearest event-volume peer: Automated Insulin Dosing Device System, Single Hormonal Control (4,787 report gap)
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor sits #5 of 1000 among tracked device types with 890,539 MAUDE reports spanning 2004–2026. 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 carries 85.5% MALFUNCTION-coded reports, 20.7pp 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 (-1.3 pp)
- INJ 14.2% corpus 30.3% · below corpus mean (-16.1 pp)
- MALF 85.5% corpus 64.8% · above corpus mean (+20.7 pp)
Lead product-problem code Device Displays Incorrect Message is 26% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 68% of manufacturer-tagged reports · Top event location I is 57% of location-tagged rows .
Pump in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Alternate Con…
Alternate Controller Enabled Insulin Infusion Pump
1,260,826 reports
- Pump (this)
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
890,539 reports
- Automated Ins…
Automated Insulin Dosing Device System, Single Hormonal Control
885,752 reports
- Pump
Pump, Infusion, Insulin
539,077 reports
- Automated Ins… 439,398
Automated Insulin Dosing , Threshold Suspend
439,398 reports
- System 431,358
System, Test, Blood Glucose, Over The Counter
431,358 reports
What this shows Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor carries 890,539 MAUDE reports, ranked #5 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 12,365 in 2025, down from an average of 20,995 in the two years before.
Related Entities for Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Top Manufacturers
Event Locations
Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC MINIMED →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Pump: 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 (890,539 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2,249 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Pump 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; 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.