Alternate Controller Enabled Insulin Infusion Pump
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 Alternate Controller Enabled Insulin Infusi… HEAVY-BOOK · MAUDE
#4 of 1000 · 1,088,188 reports · 2020–2026
- BOOK 1,088,188 reports
- RANK #4 of 1000
- DEATH 213 death-typed
- INJ 114,774 injury-typed
- MALF 973,191 malfunction
- SPAN 2020–2026
- PEAK 2025: 328,240
- PHOTO Pump
Nearest event-volume peer: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (201,487 report gap)
Alternate Controller Enabled Insulin Infusion Pump sits #4 of 1000 among tracked device types with 1,088,188 MAUDE reports spanning 2020–2026. 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 →
Event-type mix vs corpus
Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 10.5% corpus 30.4% · below corpus mean (-19.9 pp)
- MALF 89.4% corpus 64.5% · above corpus mean (+24.9 pp)
Lead product-problem code Pumping Stopped is 27% of coded problems · Lead manufacturer TANDEM DIABETES CARE accounts for 85% of manufacturer-tagged reports · Top event location is 92% of location-tagged rows .
Alternate Controller Enabled Insulin Infusi… in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Alternate Con… (this)
Alternate Controller Enabled Insulin Infusion Pump
1,088,188 reports
- Pump
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
886,701 reports
- Automated Ins…
Automated Insulin Dosing Device System, Single Hormonal Control
838,920 reports
- Pump
Pump, Infusion, Insulin
534,449 reports
- Automated Ins…
Automated Insulin Dosing , Threshold Suspend
438,789 reports
- System 429,427
System, Test, Blood Glucose, Over The Counter
429,427 reports
What this shows Alternate Controller Enabled Insulin Infusion Pump carries 1,088,188 MAUDE reports, ranked #4 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
Related Entities for Alternate Controller Enabled Insulin Infusion Pump
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Alternate Controller Enabled Insulin Infusi…, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,088,188 here).
Similar death-typed counts
Nearest other device types by death-typed report count (213 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Alternate Controller Enabled Insulin Infusi… 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 Alternate Controller Enabled Insulin Infusi…; 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.