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2026 data FDA MAUDE openFDA

Immunoassay Method, Troponin Subunit

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 Immunoassay Method, Troponin Subunit MID-BOOK · MAUDE

#145 of 1000 · 17,726 reports · 1996–2026

  • BOOK 17,726 reports
  • RANK #145 of 1000
  • DEATH 13 death-typed
  • INJ 1,554 injury-typed
  • MALF 15,448 malfunction
  • SPAN 1996–2026
  • PEAK 2011: 2,405
  • PHOTO Motor

Nearest event-volume peer: Motor, Surgical Instrument, Ac-Powered (10 report gap)

Immunoassay Method, Troponin Subunit sits #145 of 1000 among tracked device types with 17,726 MAUDE reports spanning 1996–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 8.8% corpus 30.4% · below corpus mean (-21.7 pp)
  • MALF 87.1% corpus 64.5% · above corpus mean (+22.6 pp)

Lead product-problem code High Test Results is 55% of coded problems · Lead manufacturer BECKMAN COULTER, INC. accounts for 16% of manufacturer-tagged reports · Top event location is 79% of location-tagged rows .

Immunoassay Method, Troponin Subunit in the event-volume neighbourhood

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

reports

What this shows Immunoassay Method, Troponin Subunit carries 17,726 MAUDE reports, ranked #145 of 1000.

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

Event Types

Malfunction 15,448 (87.1%)
Injury 1,554 (8.8%)
Other 658 (3.7%)
53 (0.3%)
Death 13 (0.1%)

Patient Outcomes

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

15,854 (88.6%)
Hospitalization 962 (5.4%)
Other 719 (4.0%)
Required Intervention 92 (0.5%)
O 85 (0.5%)
R 75 (0.4%)
Disability 63 (0.4%)
Death 18 (0.1%)
Life Threatening 7 (0.0%)
Congenital Anomaly 6 (0.0%)
L 5 (0.0%)
H 3 (0.0%)
S 2 (0.0%)
D 1 (0.0%)

Top Product Problems

High Test Results 3,866
False Positive Result 883
Non Reproducible Results 828
Low Test Results 331
Incorrect, Inadequate or Imprecise Result or Readings 305
False Negative Result 216
Adverse Event Without Identified Device or Use Problem 149
No Apparent Adverse Event 110
Incorrect Or Inadequate Test Results 86
Incorrect Measurement 75
High Readings 47
Output Problem 33
Low Readings 16
Insufficient Information 15
Device Displays Incorrect Message 10
Unable to Obtain Readings 9
Failure to Obtain Sample 7
Appropriate Term/Code Not Available 6
Unexpected Therapeutic Results 6
Material Integrity Problem 5

Yearly Trend

96
1996: 5
97
1997: 1
98
1998: 4
99
1999: 3
00
2000: 3
01
2001: 20
02
2002: 26
03
2003: 29
04
2004: 87
05
2005: 156
06
2006: 253
07
2007: 352
08
2008: 837
09
2009: 1,010
10
2010: 1,335
11
2011: 2,405
12
2012: 1,841
13
2013: 1,394
14
2014: 1,150
15
2015: 831
16
2016: 487
17
2017: 618
18
2018: 487
19
2019: 521
20
2020: 387
21
2021: 356
22
2022: 507
23
2023: 748
24
2024: 921
25
2025: 818
26
2026: 134

Related Entities for Immunoassay Method, Troponin Subunit

Top Manufacturers

BECKMAN COULTER, INC. 1,846
ORTHO-CLINICAL DIAGNOSTICS 1,817
BECKMAN COULTER 1,672
ROCHE DIAGNOSTICS 1,638
ABBOTT LABORATORIES 1,378
BECKMAN COULTER INC. 1,285
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1,150
SIEMENS HEALTHCARE DIAGNOSTICS INC. 937

Event Locations

14,030 (79.1%)
I 2,984 (16.8%)
LABORATORY 369 (2.1%)
OTHER 193 (1.1%)
HOSPITAL 48 (0.3%)
NOT APPLICABLE 46 (0.3%)
NO INFORMATION 40 (0.2%)
EMERGENCY ROOM 5 (0.0%)
UNKNOWN 4 (0.0%)
AMBULATORY HEALTH CARE FACILITY 2 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 2 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare BECKMAN COULTER, INC. vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Immunoassay Method, Troponin Subunit, 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 (17,726 here).

Motor, Surgical Instrument, Ac-Powered 17,736 Implant, Intragastric For Morbid Obesity 17,588 General Surgery Tray 17,567 Device, Incontinence, Mechanical/Hydraulic 17,504

Similar death-typed counts

Nearest other device types by death-typed report count (13 here), distinct from the volume row.

Apparatus 13 Chair, With Casters 13 Continuous Measurement Thermometer 13 Instrument, Coagulation, Automated 13

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

Disclaimer: MAUDE figures for Immunoassay Method, Troponin Subunit 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 Immunoassay Method, Troponin Subunit; 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.