Automated Insulin Dosing Device System, Single Hormonal Control
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 Automated Insulin Dosing Device System HEAVY-BOOK · MAUDE
#6 of 1000 · 838,920 reports · 2015–2026
- BOOK 838,920 reports
- RANK #6 of 1000
- DEATH 1,227 death-typed
- INJ 122,353 injury-typed
- MALF 715,337 malfunction
- SPAN 2015–2026
- PEAK 2022: 154,932
- PHOTO Pump
Nearest event-volume peer: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (47,781 report gap)
Automated Insulin Dosing Device System, Single Hormonal Control sits #6 of 1000 among tracked device types with 838,920 MAUDE reports spanning 2015–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 14.6% corpus 30.4% · below corpus mean (-15.9 pp)
- MALF 85.3% corpus 64.5% · above corpus mean (+20.8 pp)
Lead product-problem code Power Problem is 13% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 90% of manufacturer-tagged reports · Top event location is 85% of location-tagged rows .
Automated Insulin Dosing Device System 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
1,088,188 reports
- Pump
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
886,701 reports
- Automated Ins… (this)
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 Automated Insulin Dosing Device System, Single Hormonal Control carries 838,920 MAUDE reports, ranked #6 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 Automated Insulin Dosing Device System, Single Hormonal Control
Top Manufacturers
Event Locations
Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC MINIMED →
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Automated Insulin Dosing Device System, 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 (838,920 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1,227 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Automated Insulin Dosing Device System 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 Automated Insulin Dosing Device System; 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.