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Test, Natriuretic Peptide

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FDA MAUDE adverse event data · 2006–2026

What the Data Shows About Test, Natriuretic Peptide

The FDA MAUDE database aggregates 459 adverse-event reports for Test, Natriuretic Peptide spanning the period from 2006 through 2026. Of these, 3 are classified as death reports, 28 as injury reports, and 391 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 9 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Low Test Results topping the list at 70 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 20 years of MAUDE data, with the peak single-year volume reaching 70 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 6 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

459
Total Reports
3
Death Reports
28
Injury Reports
391
Malfunctions

Event Types

Malfunction 391 (85.2%)
Other 32 (7.0%)
Injury 28 (6.1%)
5 (1.1%)
Death 3 (0.7%)

Patient Outcomes

420 (90.3%)
Hospitalization 23 (4.9%)
Other 8 (1.7%)
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 70
Incorrect, Inadequate or Imprecise Result or Readings 24
High Test Results 19
Non Reproducible Results 18
Incorrect Or Inadequate Test Results 9
Low Readings 5
False Negative Result 4
False Positive Result 4
Adverse Event Without Identified Device or Use Problem 3
High Readings 3
Component Missing 2
Insufficient Information 2
Appropriate Term/Code Not Available 1
Calibration Problem 1
Device Issue 1
Device Markings/Labelling Problem 1
Failure to Calibrate 1
Improper or Incorrect Procedure or Method 1
Incorrect Measurement 1
Output Problem 1

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: 4

Related Entities for Test, Natriuretic Peptide

Event Locations

344 (74.9%)
I 81 (17.6%)
LABORATORY 15 (3.3%)
OTHER 13 (2.8%)
HOSPITAL 3 (0.7%)
NO INFORMATION 3 (0.7%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.