2026 data FDA MAUDE openFDA

Pump, Infusion, Insulin

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 Pump, Infusion, Insulin HEAVY-BOOK · MAUDE

#7 of 1000 · 534,449 reports · 1992–2026

  • BOOK 534,449 reports
  • RANK #7 of 1000
  • DEATH 1,407 death-typed
  • INJ 95,739 injury-typed
  • MALF 435,521 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 69,136
  • PHOTO Automated Insulin Dos…

Nearest event-volume peer: Automated Insulin Dosing , Threshold Suspend (95,660 report gap)

Pump, Infusion, Insulin sits #7 of 1000 among tracked device types with 534,449 MAUDE reports spanning 1992–2026. 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 (-1.3 pp)
  • INJ 17.9% corpus 30.4% · below corpus mean (-12.5 pp)
  • MALF 81.5% corpus 64.5% · above corpus mean (+17.0 pp)

Lead product-problem code Unintended Movement is 14% of coded problems · Lead manufacturer ANIMAS CORPORATION accounts for 32% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Pump, Infusion, Insulin in the event-volume neighbourhood

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

reports

What this shows Pump, Infusion, Insulin carries 534,449 MAUDE reports, ranked #7 of 1000.

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

Event Types

Malfunction 435,521 (81.5%)
Injury 95,739 (17.9%)
Death 1,407 (0.3%)
1,068 (0.2%)
Other 714 (0.1%)

Patient Outcomes

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

438,972 (79.6%)
Hospitalization 41,385 (7.5%)
Other 31,513 (5.7%)
R 12,581 (2.3%)
Required Intervention 11,009 (2.0%)
Life Threatening 9,767 (1.8%)
L 2,807 (0.5%)
Death 1,409 (0.3%)
O 1,054 (0.2%)
H 626 (0.1%)
S 113 (0.0%)
Disability 64 (0.0%)
Congenital Anomaly 11 (0.0%)
D 8 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Unintended Movement 38,618
Material Twisted/Bent 34,290
Loss of or Failure to Bond 23,843
Insufficient Information 18,732
Device Displays Incorrect Message 16,972
Pumping Stopped 16,920
Mechanical Problem 14,829
Adverse Event Without Identified Device or Use Problem 12,087
Failure to Fire 11,298
Incorrect Measurement 9,848
Activation, Positioning or Separation Problem 9,717
Fluid/Blood Leak 8,919
Device Operates Differently Than Expected 8,697
Difficult to Insert 8,545
Obstruction of Flow 6,760
Battery Problem 6,587
Premature Activation 6,521
Charging Problem 6,419
Occlusion Within Device 6,239
Failure to Prime 5,394

Yearly Trend

92
1992: 4
93
1993: 1
94
1994: 7
95
1995: 6
96
1996: 61
97
1997: 170
98
1998: 204
99
1999: 294
00
2000: 341
01
2001: 598
02
2002: 1,001
03
2003: 2,105
04
2004: 3,299
05
2005: 3,209
06
2006: 4,099
07
2007: 5,110
08
2008: 5,711
09
2009: 9,471
10
2010: 10,174
11
2011: 12,854
12
2012: 18,365
13
2013: 30,055
14
2014: 49,181
15
2015: 69,136
16
2016: 56,584
17
2017: 44,472
18
2018: 32,652
19
2019: 29,027
20
2020: 32,588
21
2021: 31,522
22
2022: 28,225
23
2023: 21,972
24
2024: 18,228
25
2025: 12,151
26
2026: 1,572

Related Entities for Pump, Infusion, Insulin

Event Locations

255,443 (47.8%)
I 254,928 (47.7%)
OTHER 10,974 (2.1%)
HOME 4,727 (0.9%)
NOT APPLICABLE 2,965 (0.6%)
U 2,918 (0.5%)
NO INFORMATION 2,009 (0.4%)
HOSPITAL 150 (0.0%)
UNKNOWN 148 (0.0%)
INVALID DATA 96 (0.0%)
SCHOOL 35 (0.0%)
OUTPATIENT TREATMENT FACILITY 10 (0.0%)
LABORATORY 9 (0.0%)
OUTDOORS 9 (0.0%)
CLINIC - WALK IN, OTHER 6 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.0%)
PUBLIC VENUE 4 (0.0%)
NURSING HOME 3 (0.0%)
PUBLIC BUILDING 2 (0.0%)
REHABILITATION CENTER 2 (0.0%)
STREET 2 (0.0%)
AMBULATORY HEALTH CARE FACILITY 1 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
PARK 1 (0.0%)

Compare ANIMAS CORPORATION vs INSULET CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Pump, Infusion, Insulin, 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 (534,449 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,407 here), distinct from the volume row.

Disclaimer: MAUDE figures for Pump, Infusion, Insulin 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 Pump, Infusion, Insulin; 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.