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2026 data FDA MAUDE openFDA FDA Class II

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.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §862.1215 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Immunoassay Method, Troponin Subunit MID-BOOK · MAUDE

#152 of 1000 · 18,095 reports · 1996–2026

  • BOOK 18,095 reports
  • RANK #152 of 1000
  • DEATH 13 death-typed
  • INJ 1,555 injury-typed
  • MALF 15,816 malfunction
  • SPAN 1996–2026
  • PEAK 2011: 2,405
  • PHOTO Humidifier

Nearest event-volume peer: Humidifier, Respiratory Gas, (Direct Patient Interface) (23 report gap)

Immunoassay Method, Troponin Subunit sits #152 of 1000 among tracked device types with 18,095 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 →

Malfunction reports run above the device-type norm

Immunoassay Method, Troponin Subunit carries 87.4% MALFUNCTION-coded reports, 22.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 8.6% corpus 30.3% · below corpus mean (-21.7 pp)
  • MALF 87.4% corpus 64.8% · 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 80% 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 18,095 MAUDE reports, ranked #152 of 1000.

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

Event Types

Malfunction 15,816 (87.4%)
Injury 1,555 (8.6%)
Other 658 (3.6%)
53 (0.3%)
Death 13 (0.1%)

Patient Outcomes

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

16,077 (88.7%)
Hospitalization 962 (5.3%)
Other 720 (4.0%)
Required Intervention 92 (0.5%)
O 85 (0.5%)
R 75 (0.4%)
Disability 63 (0.3%)
Death 18 (0.1%)
Life Threatening 8 (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 10,902
Incorrect Or Inadequate Test Results 2,464
False Positive Result 2,411
Non Reproducible Results 907
Low Test Results 835
Incorrect, Inadequate or Imprecise Result or Readings 550
False Negative Result 433
Nonstandard Device 274
Adverse Event Without Identified Device or Use Problem 170
No Apparent Adverse Event 110
Defective Device 90
Incorrect Measurement 87
High Readings 72
Device Displays Incorrect Message 63
Device Operates Differently Than Expected 59
Use of Device Problem 59
Improper or Incorrect Procedure or Method 48
Other (for use when an appropriate device code cannot be identified) 42
Calibration Problem 41
Output Problem 40

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: 503

Reports in 2025 (818) held close to the prior two-year average of 835.

Related Entities for Immunoassay Method, Troponin Subunit

Top Manufacturers

BECKMAN COULTER, INC. 1,846
ORTHO-CLINICAL DIAGNOSTICS 1,817
ROCHE DIAGNOSTICS 1,719
BECKMAN COULTER 1,672
ABBOTT LABORATORIES 1,385
BECKMAN COULTER INC. 1,285
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1,181
SIEMENS HEALTHCARE DIAGNOSTICS INC. 958

Event Locations

14,399 (79.6%)
I 2,984 (16.5%)
LABORATORY 369 (2.0%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Immunoassay Method, Troponin Subunit: 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 (18,095 here).

Humidifier, Respiratory Gas, 18,072 Motor, Surgical Instrument, Ac-Powered 18,194 Phakic Toric Intraocular Lens 18,233 Device, Incontinence, Mechanical/Hydraulic 18,299

Similar death-typed counts

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

Apparatus 13 Bariatric Bed 13 Chair, With Casters 13 Continuous Measurement Thermometer 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.