2026 data FDA MAUDE openFDA

Covid-19 Multi-Analyte Antigen Device

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 MAUDE casebook

openFDA event book Covid-19 Multi-Analyte Antigen Device LIGHT-BOOK · MAUDE

#361 of 1000 · 3,840 reports · 2020–2026

  • BOOK 3,840 reports
  • RANK #361 of 1000
  • DEATH 0 death-typed
  • INJ 11 injury-typed
  • MALF 3,829 malfunction
  • SPAN 2020–2026
  • PEAK 2022: 2,208
  • PHOTO Analyzer

Nearest event-volume peer: Analyzer, Pacemaker Generator Function (3 report gap)

Covid-19 Multi-Analyte Antigen Device sits #361 of 1000 among tracked device types with 3,840 MAUDE reports spanning 2020–2026. 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

Covid-19 Multi-Analyte Antigen Device carries 99.7% MALFUNCTION-coded reports, 34.9pp above 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 0.3% corpus 30.3% · below corpus mean (-30.0 pp)
  • MALF 99.7% corpus 64.8% · above corpus mean (+34.9 pp)

Lead product-problem code No Apparent Adverse Event is 46% of coded problems · Lead manufacturer QUIDEL CORPORATION accounts for 97% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Covid-19 Multi-Analyte Antigen Device in the event-volume neighbourhood

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

reports

What this shows Covid-19 Multi-Analyte Antigen Device carries 3,840 MAUDE reports, ranked #361 of 1000.

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

Event Types

Malfunction 3,829 (99.7%)
Injury 11 (0.3%)

Patient Outcomes

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

3,808 (99.4%)
Other 17 (0.4%)
Required Intervention 6 (0.2%)

Top Product Problems

No Apparent Adverse Event 3,303
False Positive Result 2,986
False Negative Result 466
Imprecise or Erratic Results 172
Incorrect, Inadequate or Imprecise Result or Readings 103
Unable to Obtain Readings 82
Non Reproducible Results 11
Device Markings/Labelling Problem 8
Contamination of Device Ingredient or Reagent 2
Device Contaminated During Manufacture or Shipping 2
Device Handling Problem 2
Inaccurate Information 2
Insufficient Device Problem Information 2
Leak/Splash 2
Product Quality Problem 2
High Readings 1

Yearly Trend

20
2020: 1
21
2021: 40
22
2022: 2,208
23
2023: 576
24
2024: 407
25
2025: 388
26
2026: 220

Reports in 2025 (388) held close to the prior two-year average of 492.

Related Entities for Covid-19 Multi-Analyte Antigen Device

Event Locations

3,838 (99.9%)
NO INFORMATION 2 (0.1%)

Compare QUIDEL CORPORATION vs BECTON, DICKINSON & CO. (SPARKS) →

Nationwide devices with a comparable report-volume footprint

Covid-19 Multi-Analyte Antigen Device 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 (3,840 here).

Similar death-typed counts

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

Disclaimer: MAUDE figures for Covid-19 Multi-Analyte Antigen Device 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 Covid-19 Multi-Analyte Antigen Device; 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.