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2026 data FDA MAUDE openFDA

Automated Insulin Dosing , Threshold Suspend

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 , Threshold Suspend HEAVY-BOOK · MAUDE

#8 of 1000 · 438,789 reports · 2014–2026

  • BOOK 438,789 reports
  • RANK #8 of 1000
  • DEATH 1,530 death-typed
  • INJ 90,580 injury-typed
  • MALF 346,609 malfunction
  • SPAN 2014–2026
  • PEAK 2019: 82,392
  • PHOTO System

Nearest event-volume peer: System, Test, Blood Glucose, Over The Counter (9,362 report gap)

Automated Insulin Dosing , Threshold Suspend sits #8 of 1000 among tracked device types with 438,789 MAUDE reports spanning 2014–2026. 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 20.6% corpus 30.4% · below corpus mean (-9.8 pp)
  • MALF 79.0% corpus 64.5% · above corpus mean (+14.5 pp)

Lead product-problem code Break is 10% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 60% of manufacturer-tagged reports · Top event location I is 60% of location-tagged rows .

Automated Insulin Dosing , Threshold Suspend in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Automated Insulin Dosing , Threshold Suspend carries 438,789 MAUDE reports, ranked #8 of 1000.

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

Event Types

Malfunction 346,609 (79.0%)
Injury 90,580 (20.6%)
Death 1,530 (0.3%)
57 (0.0%)
Other 13 (0.0%)

Patient Outcomes

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

353,469 (79.2%)
Other 58,558 (13.1%)
Hospitalization 18,486 (4.1%)
Required Intervention 5,878 (1.3%)
R 3,933 (0.9%)
H 2,122 (0.5%)
O 1,554 (0.3%)
Death 1,399 (0.3%)
Life Threatening 455 (0.1%)
L 404 (0.1%)
D 112 (0.0%)
S 29 (0.0%)
Congenital Anomaly 13 (0.0%)
Disability 6 (0.0%)
C 2 (0.0%)

Top Product Problems

Break 40,026
Device Displays Incorrect Message 39,989
Adverse Event Without Identified Device or Use Problem 37,143
Patient Device Interaction Problem 33,286
Obstruction of Flow 30,994
Pumping Stopped 28,483
Power Problem 25,962
No Display/Image 25,384
Mechanical Problem 18,067
Battery Problem 17,384
Material Integrity Problem 15,639
Device Difficult to Program or Calibrate 15,096
Incorrect Measurement 14,177
No Apparent Adverse Event 13,601
Charging Problem 13,098
Appropriate Term/Code Not Available 12,530
Failure to Sense 9,796
Connection Problem 8,893
Crack 8,441
Physical Resistance/Sticking 6,823

Yearly Trend

14
2014: 15,080
15
2015: 28,763
16
2016: 21,283
17
2017: 30,435
18
2018: 39,960
19
2019: 82,392
20
2020: 77,812
21
2021: 42,577
22
2022: 54,924
23
2023: 29,739
24
2024: 11,814
25
2025: 3,653
26
2026: 357

Related Entities for Automated Insulin Dosing , Threshold Suspend

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 263,392
TANDEM DIABETES CARE 143,626
MEDTRONIC MINIMED 30,428
DEXCOM, INC. 248
MEDTRONIC PUERTO RICO OPERATIONS CO 112
MEDTRONIC 44
TANDEM DIABETES CARE, INC. 30

Event Locations

I 263,541 (60.1%)
174,589 (39.8%)
NO INFORMATION 658 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs TANDEM DIABETES CARE →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Automated Insulin Dosing , Threshold Suspend, 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 (438,789 here).

System 429,427 Implantable Cardioverter Defibrillator 369,312 Stimulator 362,034 Pump, Infusion, Insulin 534,449

Similar death-typed counts

Nearest other device types by death-typed report count (1,530 here), distinct from the volume row.

System, Balloon, Intra-Aortic And Control 1,451 Pump, Infusion, Implanted, Programmable 1,628 Mitral Valve Repair Devices 1,414 System, Appendage Closure, Left Atrial 1,702

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Automated Insulin Dosing , Threshold Suspend 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 , Threshold Suspend; 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.