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2026 data FDA MAUDE openFDA FDA Class III

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.

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FDA MAUDE casebook

openFDA event book Automated Insulin Dosing Device System HEAVY-BOOK · MAUDE

#6 of 1000 · 885,752 reports · 2015–2026

  • BOOK 885,752 reports
  • RANK #6 of 1000
  • DEATH 1,254 death-typed
  • INJ 127,210 injury-typed
  • MALF 757,285 malfunction
  • SPAN 2015–2026
  • PEAK 2022: 154,932
  • PHOTO Pump

Nearest event-volume peer: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (4,787 report gap)

Automated Insulin Dosing Device System, Single Hormonal Control sits #6 of 1000 among tracked device types with 885,752 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 →

Malfunction reports run above the device-type norm

Automated Insulin Dosing Device System 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 14.4% corpus 30.3% · below corpus mean (-15.9 pp)
  • MALF 85.5% corpus 64.8% · above corpus mean (+20.7 pp)

Lead product-problem code Break 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

reports

What this shows Automated Insulin Dosing Device System, Single Hormonal Control carries 885,752 MAUDE reports, ranked #6 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 757,285 (85.5%)
Injury 127,210 (14.4%)
Death 1,254 (0.1%)
2 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

757,390 (84.2%)
Other 95,812 (10.6%)
Hospitalization 17,777 (2.0%)
Required Intervention 10,901 (1.2%)
R 7,082 (0.8%)
H 6,936 (0.8%)
O 2,469 (0.3%)
Death 1,014 (0.1%)
D 229 (0.0%)
Life Threatening 79 (0.0%)
L 63 (0.0%)
Disability 49 (0.0%)
S 47 (0.0%)
Congenital Anomaly 29 (0.0%)
C 2 (0.0%)

Top Product Problems

Break 143,383
Power Problem 141,080
Obstruction of Flow 102,284
Adverse Event Without Identified Device or Use Problem 87,077
Material Integrity Problem 63,536
No Display/Image 63,133
Patient Device Interaction Problem 62,682
Appropriate Device Problem Term/Code Not Available 60,621
Mechanical Problem 46,885
Battery Problem 46,083
Wireless Communication Problem 46,007
Incorrect, Inadequate or Imprecise Result or Readings 35,939
Moisture or Humidity Problem 34,382
Key or Button Unresponsive/not Working 28,605
No Apparent Adverse Event 25,759
Device Difficult to Program or Calibrate 24,265
Insufficient Flow or Under Infusion 21,844
Communication or Transmission Problem 20,696
Connection Problem 20,664
Circuit Failure 19,223

Yearly Trend

15
2015: 13
16
2016: 63
17
2017: 3,606
18
2018: 30,849
19
2019: 55,507
20
2020: 74,042
21
2021: 66,221
22
2022: 154,932
23
2023: 145,197
24
2024: 129,592
25
2025: 152,969
26
2026: 72,761

Reports in 2025 (152,969) held close to the prior two-year average of 137,395.

Related Entities for Automated Insulin Dosing Device System, Single Hormonal Control

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 799,875
MEDTRONIC MINIMED 82,825
Medtronic Puerto Rico Operations Co. 2,920
MEDTRONIC 16
MEDTRONIC INC. 8
MEDTRONIC, INC. 7

Event Locations

756,941 (85.5%)
I 128,646 (14.5%)
NO INFORMATION 165 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC MINIMED →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Automated Insulin Dosing Device System: 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 (885,752 here).

Pump 890,539 Pump, Infusion, Insulin 539,077 Alternate Controller Enabled Insulin Infusi… 1,260,826 Automated Insulin Dosing , Threshold Suspend 439,398

Similar death-typed counts

Nearest other device types by death-typed report count (1,254 here), distinct from the volume row.

Leadless Pacemaker 1,257 Replacement Heart-Valve 1,336 Introducer, Catheter 1,345 Staple, Implantable 1,100

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.