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2026 data FDA MAUDE openFDA FDA Class III

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 · 439,398 reports · 2014–2026

  • BOOK 439,398 reports
  • RANK #8 of 1000
  • DEATH 1,532 death-typed
  • INJ 90,673 injury-typed
  • MALF 347,123 malfunction
  • SPAN 2014–2026
  • PEAK 2019: 82,392
  • PHOTO System

Nearest event-volume peer: System, Test, Blood Glucose, Over The Counter (8,040 report gap)

Automated Insulin Dosing , Threshold Suspend sits #8 of 1000 among tracked device types with 439,398 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 →

Malfunction reports run above the device-type norm

Automated Insulin Dosing , Threshold Suspend carries 79.0% MALFUNCTION-coded reports, 14.2pp 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 (-1.2 pp)
  • INJ 20.6% corpus 30.3% · below corpus mean (-9.7 pp)
  • MALF 79.0% corpus 64.8% · above corpus mean (+14.2 pp)

Lead product-problem code Device Displays Incorrect Message is 13% 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 439,398 MAUDE reports, ranked #8 of 1000.

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

Event Types

Malfunction 347,123 (79.0%)
Injury 90,673 (20.6%)
Death 1,532 (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.

353,911 (79.2%)
Other 58,533 (13.1%)
Hospitalization 18,504 (4.1%)
Required Intervention 5,906 (1.3%)
R 3,953 (0.9%)
H 2,135 (0.5%)
O 1,554 (0.3%)
Death 1,400 (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

Device Displays Incorrect Message 56,537
Break 41,745
Adverse Event Without Identified Device or Use Problem 39,315
Patient Device Interaction Problem 33,286
Obstruction of Flow 31,147
Pumping Stopped 28,545
No Display/Image 27,293
Power Problem 26,022
Mechanical Problem 18,188
Battery Problem 18,161
Material Integrity Problem 16,900
Device Difficult to Program or Calibrate 15,099
Incorrect Measurement 14,183
No Apparent Adverse Event 13,601
Charging Problem 13,111
Appropriate Device Problem Term/Code Not Available 12,619
Device Operates Differently Than Expected 10,156
Failure to Sense 9,850
Crack 9,440
Connection Problem 9,068

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: 966

Reports fell to 3,653 in 2025, down from an average of 20,777 in the two years before.

Related Entities for Automated Insulin Dosing , Threshold Suspend

Top Manufacturers

MEDTRONIC PUERTO RICO OPERATIONS CO. 263,972
TANDEM DIABETES CARE 143,626
MEDTRONIC MINIMED 30,428
DEXCOM, INC. 248
MEDTRONIC PUERTO RICO OPERATIONS CO 112
MEDTRONIC 44
TANDEM DIABETES CARE, INC. 31
Medtronic Puerto Rico Operations Co. 26

Event Locations

I 263,460 (60.0%)
175,279 (39.9%)
NO INFORMATION 658 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Automated Insulin Dosing , Threshold Suspend: 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 (439,398 here).

System 431,358 Implantable Cardioverter Defibrillator 379,353 Stimulator 375,710 Pump, Infusion, Insulin 539,077

Similar death-typed counts

Nearest other device types by death-typed report count (1,532 here), distinct from the volume row.

System, Balloon, Intra-Aortic And Control 1,470 Pump, Infusion, Implanted, Programmable 1,634 Introducer, Catheter 1,345 Replacement Heart-Valve 1,336

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.