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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §880.5730 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Alternate Controller Enabled Insulin Infusi… HEAVY-BOOK · MAUDE

#4 of 1000 · 1,260,826 reports · 2020–2026

  • BOOK 1,260,826 reports
  • RANK #4 of 1000
  • DEATH 319 death-typed
  • INJ 138,643 injury-typed
  • MALF 1,121,833 malfunction
  • SPAN 2020–2026
  • PEAK 2025: 328,240
  • PHOTO Pump

Nearest event-volume peer: Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (370,287 report gap)

Alternate Controller Enabled Insulin Infusion Pump sits #4 of 1000 among tracked device types with 1,260,826 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 →

Malfunction reports run above the device-type norm

Alternate Controller Enabled Insulin Infusi… carries 89.0% MALFUNCTION-coded reports, 24.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 11.0% corpus 30.3% · below corpus mean (-19.3 pp)
  • MALF 89.0% corpus 64.8% · above corpus mean (+24.1 pp)

Lead product-problem code Pumping Stopped is 27% of coded problems · Lead manufacturer TANDEM DIABETES CARE accounts for 81% of manufacturer-tagged reports · Top event location is 93% 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

reports

What this shows Alternate Controller Enabled Insulin Infusion Pump carries 1,260,826 MAUDE reports, ranked #4 of 1000.

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

Event Types

Malfunction 1,121,833 (89.0%)
Injury 138,643 (11.0%)
Death 319 (0.0%)
Other 28 (0.0%)
3 (0.0%)

Patient Outcomes

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

1,164,312 (92.1%)
Other 51,157 (4.0%)
Required Intervention 19,357 (1.5%)
Hospitalization 15,712 (1.2%)
R 5,764 (0.5%)
H 3,626 (0.3%)
Life Threatening 2,266 (0.2%)
L 1,425 (0.1%)
O 855 (0.1%)
Death 240 (0.0%)
Disability 72 (0.0%)
S 33 (0.0%)
D 11 (0.0%)
Congenital Anomaly 2 (0.0%)
C 1 (0.0%)

Top Product Problems

Pumping Stopped 345,361
Charging Problem 94,743
Incorrect Measurement 86,914
Unintended Movement 80,740
Obstruction of Flow 80,232
Loss of or Failure to Bond 73,893
Battery Problem 67,857
Communication or Transmission Problem 59,369
Adverse Event Without Identified Device or Use Problem 57,973
Failure to Sense 42,257
Insufficient Device Problem Information 39,375
Mechanical Problem 35,339
Material Twisted/Bent 33,722
Filling Problem 31,774
False Alarm 30,327
Crack 25,405
Failure to Charge 23,223
Device Sensing Problem 20,644
Poor Quality Image 20,026
Fluid/Blood Leak 19,182

Yearly Trend

20
2020: 30,522
21
2021: 74,701
22
2022: 129,119
23
2023: 188,014
24
2024: 273,190
25
2025: 328,240
26
2026: 237,040

Reports rose to 328,240 in 2025, up from an average of 230,602 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Alternate Controller Enabled Insulin Infusion Pump

Top Manufacturers

TANDEM DIABETES CARE 1,014,922
INSULET CORPORATION 166,256
BETA BIONICS INC. 36,597
BETA BIONICS, INC. 17,414
MEDTRONIC PUERTO RICO OPERATIONS CO. 8,677
Tandem Diabetes Care 7,283
Insulet Corporation 3,300
Beta Bionics, Inc. 1,520
BETA BIONICS INC 1,033
Medtronic Puerto Rico Operations Co. 965

Event Locations

1,174,585 (93.2%)
I 86,236 (6.8%)
HOME 4 (0.0%)
N 1 (0.0%)

Compare TANDEM DIABETES CARE vs INSULET CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Alternate Controller Enabled Insulin Infusi…: 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 (1,260,826 here).

Pump 890,539 Automated Insulin Dosing Device System 885,752 Pump, Infusion 1,827,009 Pump, Infusion, Insulin 539,077

Similar death-typed counts

Nearest other device types by death-typed report count (319 here), distinct from the volume row.

Sensor, Glucose, Invasive 321 Acid, Hyaluronic, Intraarticular 307 Catheter 307 Set 307

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.