2026 data FDA MAUDE openFDA

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

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 Respiratory Panel Nu… LIGHT-BOOK · MAUDE

#536 of 1000 · 1,693 reports · 2021–2026

  • BOOK 1,693 reports
  • RANK #536 of 1000
  • DEATH 0 death-typed
  • INJ 2 injury-typed
  • MALF 1,691 malfunction
  • SPAN 2021–2026
  • PEAK 2022: 900
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Ankle, Uncemented, Non-Constrained (1 report gap)

Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices sits #536 of 1000 among tracked device types with 1,693 MAUDE reports spanning 2021–2026. 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 Respiratory Panel Nu… carries 99.9% MALFUNCTION-coded reports, 35.1pp 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 0.1% corpus 30.3% · below corpus mean (-30.2 pp)
  • MALF 99.9% corpus 64.8% · above corpus mean (+35.1 pp)

Lead product-problem code Non Reproducible Results is 37% of coded problems · Lead manufacturer ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG accounts for 100% of manufacturer-tagged reports · Top event location is 93% of location-tagged rows .

Covid-19 Multi-Analyte Respiratory Panel Nu… 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 Respiratory Panel Nucleic Acid Devices carries 1,693 MAUDE reports, ranked #536 of 1000.

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

Event Types

Malfunction 1,691 (99.9%)
Injury 2 (0.1%)

Patient Outcomes

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

1,689 (99.8%)
Death 1 (0.1%)
Disability 1 (0.1%)
Other 1 (0.1%)
Required Intervention 1 (0.1%)

Top Product Problems

Non Reproducible Results 944
False Positive Result 755
Incorrect, Inadequate or Imprecise Result or Readings 389
Output Problem 355
False Negative Result 54
No Apparent Adverse Event 17
Imprecise or Erratic Results 13
No Device Output 5
Insufficient Device Problem Information 4
Unable to Obtain Readings 4
Device Sensing Problem 2
Improper or Incorrect Procedure or Method 1
Optical Problem 1
Unexpected Therapeutic Results 1

Yearly Trend

21
2021: 392
22
2022: 900
23
2023: 283
24
2024: 115
25
2025: 2
26
2026: 1

Reports fell to 2 in 2025, down from an average of 199 in the two years before.

Related Entities for Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices

Event Locations

1,578 (93.2%)
I 115 (6.8%)

Compare ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG vs HOLOGIC, INC. →

Nationwide devices with a comparable report-volume footprint

Covid-19 Multi-Analyte Respiratory Panel Nu… 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 (1,693 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 Respiratory Panel Nu… 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 Respiratory Panel Nu…; 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.