What are FDA adverse event reports for Test, Hiv Detection?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Test, Hiv Detection, there are 2,947 total reports including 4 death reports and 123 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Test, Hiv Detection?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Test, Hiv Detection

Name: Test, Hiv Detection - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Test, Hiv Detection LIGHT-BOOK · MAUDE

#399 of 1000 · 2,947 reports · 2002–2026

BOOK 2,947 reports
RANK #399 of 1000
DEATH 4 death-typed
INJ 123 injury-typed
MALF 2,732 malfunction
SPAN 2002–2026
PEAK 2025: 1,090
PHOTO Test, Hepatitis B

Nearest event-volume peer: Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) (9 report gap)

Test, Hiv Detection sits #399 of 1000 among tracked device types with 2,947 MAUDE reports spanning 2002–2026. 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 4.2% corpus 30.4% · below corpus mean (-26.3 pp)
MALF 92.7% corpus 64.5% · above corpus mean (+28.2 pp)

Lead product-problem code False Positive Result is 67% of coded problems · Lead manufacturer ABBOTT DIAGNOSTICS SCARBOROUGH, INC. accounts for 48% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .

Medical Devic…

2,961
Prosthesis

2,959
Agent

2,957
Test (this)

2,947
Test

2,938
Dilator

2,929

What this shows Test, Hiv Detection carries 2,947 MAUDE reports, ranked #399 of 1000.

Event Types

Malfunction 2,732 (92.7%)

Injury 123 (4.2%)

61 (2.1%)

Other 27 (0.9%)

Death 4 (0.1%)

Patient Outcomes

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

2,782 (94.2%)

Other 95 (3.2%)

Disability 21 (0.7%)

Required Intervention 21 (0.7%)

Hospitalization 18 (0.6%)

O 5 (0.2%)

Life Threatening 4 (0.1%)

L 2 (0.1%)

S 2 (0.1%)

D 1 (0.0%)

R 1 (0.0%)

Congenital Anomaly 1 (0.0%)

Death 1 (0.0%)

Yearly Trend

2002: 1

2003: 1

2005: 5

2006: 3

2007: 4

2008: 8

2009: 18

2010: 44

2011: 92

2012: 69

2013: 47

2014: 49

2015: 74

2016: 79

2017: 135

2018: 580

2019: 154

2020: 66

2021: 65

2022: 114

2023: 88

2024: 114

2025: 1,090

2026: 47

Top Manufacturers

ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 861

ROCHE DIAGNOSTICS 443

ABBOTT GMBH 174

ABBOTT LABORATORIES 172

SIEMENS HEALTHCARE DIAGNOSTICS, INC. 85

ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG 57

Event Locations

1,828 (62.0%)

I 1,106 (37.5%)

NO INFORMATION 6 (0.2%)

UNKNOWN 3 (0.1%)

HOSPITAL 2 (0.1%)

HOME 1 (0.0%)

OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare ABBOTT DIAGNOSTICS SCARBOROUGH, INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Test, Hiv Detection, 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 (2,947 here).

Test, Hepatitis B 2,938 Agent, Injectable, Embolic 2,957 Prosthesis, Tracheal, Expandable 2,959 Medical Device Data System 2,961

Similar death-typed counts

Nearest other device types by death-typed report count (4 here), distinct from the volume row.

Catheter, Urethral 4 Disinfectant, Medical Devices 4 Drill, Surgical, Ent Including Handpiece 4 Electrode 4

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

Disclaimer: MAUDE figures for Test, Hiv Detection 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, Hiv Detection; 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.

Test, Hiv Detection

Event-type mix vs corpus