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2023 data FDA MAUDE openFDA

Test, Qualitative, For Hla, Non-Diagnostic

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.

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FDA MAUDE casebook

openFDA event book Test, Qualitative, For Hla, Non-Diagnostic LIGHT-BOOK · MAUDE

#880 of 1000 · 511 reports · 2012–2023

  • BOOK 511 reports
  • RANK #880 of 1000
  • DEATH 0 death-typed
  • INJ 1 injury-typed
  • MALF 475 malfunction
  • SPAN 2012–2023
  • PEAK 2014: 210
  • PHOTO Cutter, Wire

Nearest event-volume peer: Cutter, Wire (1 report gap)

Test, Qualitative, For Hla, Non-Diagnostic sits #880 of 1000 among tracked device types with 511 MAUDE reports spanning 2012–2023. 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Test, Qualitative, For Hla, Non-Diagnostic carries 0.2% INJURY-coded reports, 30.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
  • MALF 93.0% corpus 64.8% · above corpus mean (+28.1 pp)

Lead product-problem code Nonstandard Device is 22% of coded problems · Top event location is 94% of location-tagged rows .

Test, Qualitative, For Hla, Non-Diagnostic in the event-volume neighbourhood

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

reports

What this shows Test, Qualitative, For Hla, Non-Diagnostic carries 511 MAUDE reports, ranked #880 of 1000.

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

Event Types

Malfunction 475 (93.0%)
33 (6.5%)
Other 2 (0.4%)
Injury 1 (0.2%)

Patient Outcomes

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

506 (99.0%)
Other 4 (0.8%)
Required Intervention 1 (0.2%)

Top Product Problems

Nonstandard Device 150
Device Operates Differently Than Expected 145
Incorrect Or Inadequate Test Results 104
Incorrect, Inadequate or Imprecise Result or Readings 77
False Negative Result 56
False Positive Result 50
Application Program Problem 31
High Test Results 23
Adverse Event Without Identified Device or Use Problem 11
Improper or Incorrect Procedure or Method 7
High Readings 5
Off-Label Use 5
Appropriate Device Problem Term/Code Not Available 4
Computer Software Problem 4
Device Displays Incorrect Message 4
Device Markings/Labelling Problem 4
Imprecision 4
Filtration Problem 3
Insufficient Device Problem Information 3
Data Problem 2

Yearly Trend

12
2012: 5
13
2013: 162
14
2014: 210
15
2015: 97
16
2016: 6
18
2018: 21
19
2019: 2
20
2020: 2
21
2021: 4
23
2023: 2

Reports rose to 4 in 2021, up from an average of 2 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Test, Qualitative, For Hla, Non-Diagnostic

Event Locations

478 (93.5%)
I 31 (6.1%)
NO INFORMATION 2 (0.4%)

Nationwide devices with a comparable report-volume footprint

Test, Qualitative, For Hla, Non-Diagnostic carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (511 here).

Cutter, Wire 510 Tubing, Pressure And Accessories 510 Infusor, Pressure, For I.V. Bags 508 Laparoscopic Accessories, Gynecologic 508

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Test, Qualitative, For Hla, Non-Diagnostic 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, Qualitative, For Hla, Non-Diagnostic; 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.