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2026 data FDA MAUDE openFDA FDA Class II

Test, Natriuretic Peptide

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 §862.1117 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Test, Natriuretic Peptide LIGHT-BOOK · MAUDE

#920 of 1000 · 467 reports · 2006–2026

  • BOOK 467 reports
  • RANK #920 of 1000
  • DEATH 3 death-typed
  • INJ 29 injury-typed
  • MALF 398 malfunction
  • SPAN 2006–2026
  • PEAK 2014: 70
  • PHOTO Injector

Nearest event-volume peer: Injector, Fluid, Non-Electrically Powered (0 report gap)

Test, Natriuretic Peptide sits #920 of 1000 among tracked device types with 467 MAUDE reports spanning 2006–2026. 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 →

Injury-coded reports sit below the device-type norm

Test, Natriuretic Peptide carries 6.2% INJURY-coded reports, 24.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 6.2% corpus 30.3% · below corpus mean (-24.1 pp)
  • MALF 85.2% corpus 64.8% · above corpus mean (+20.4 pp)

Lead product-problem code Low Test Results is 32% of coded problems · Lead manufacturer ALERE SAN DIEGO, INC. accounts for 45% of manufacturer-tagged reports · Top event location is 75% of location-tagged rows .

Test, Natriuretic Peptide in the event-volume neighbourhood

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

reports

What this shows Test, Natriuretic Peptide carries 467 MAUDE reports, ranked #920 of 1000.

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

Event Types

Malfunction 398 (85.2%)
Other 32 (6.9%)
Injury 29 (6.2%)
5 (1.1%)
Death 3 (0.6%)

Patient Outcomes

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

423 (90.2%)
Hospitalization 23 (4.9%)
Other 9 (1.9%)
O 4 (0.9%)
Required Intervention 4 (0.9%)
Death 3 (0.6%)
L 1 (0.2%)
R 1 (0.2%)
Life Threatening 1 (0.2%)

Top Product Problems

Low Test Results 171
High Test Results 82
Incorrect Or Inadequate Test Results 70
Incorrect, Inadequate or Imprecise Result or Readings 54
False Negative Result 52
False Positive Result 38
Non Reproducible Results 24
Device Operates Differently Than Expected 9
Low Readings 5
Adverse Event Without Identified Device or Use Problem 4
Improper or Incorrect Procedure or Method 4
Device Issue 3
Failure to Calibrate 3
High Readings 3
Smoking 3
Temperature Problem 3
Appropriate Device Problem Term/Code Not Available 2
Component Missing 2
Device Emits Odor 2
Failure to Power Up 2

Yearly Trend

06
2006: 2
07
2007: 17
08
2008: 15
09
2009: 35
10
2010: 61
11
2011: 53
12
2012: 23
13
2013: 13
14
2014: 70
15
2015: 43
16
2016: 31
17
2017: 9
18
2018: 7
19
2019: 9
20
2020: 6
22
2022: 4
23
2023: 26
24
2024: 14
25
2025: 17
26
2026: 12

Reports in 2025 (17) held close to the prior two-year average of 20.

Related Entities for Test, Natriuretic Peptide

Top Manufacturers

ALERE SAN DIEGO, INC. 158
ROCHE DIAGNOSTICS 86
ALERE SAN DIEGO, INC 27
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 27
ABBOTT LABORATORIES 21
ORTHO-CLINICAL DIAGNOSTICS 15
SIEMENS HEALTHCARE DIAGNOSTICS INC. 12
BECKMAN COULTER, INC. 9

Event Locations

352 (75.4%)
I 81 (17.3%)
LABORATORY 15 (3.2%)
OTHER 13 (2.8%)
HOSPITAL 3 (0.6%)
NO INFORMATION 3 (0.6%)

Compare ALERE SAN DIEGO, INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Test, Natriuretic Peptide: 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 (467 here).

Injector, Fluid, Non-Electrically Powered 467 Clip, Hemostatic 468 Connector, Airway 466 Infant Heel Warmer 466

Similar death-typed counts

Nearest other device types by death-typed report count (3 here), distinct from the volume row.

Analyzer, Pacemaker Generator Function 3 Apparatus, Traction, Non-Powered 3 Bronchial Thermoplasty System 3 Bur, Ear, Nose And Throat 3

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

Disclaimer: MAUDE figures for Test, Natriuretic Peptide 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 Test, Natriuretic Peptide; 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.