Real Time Nucleic Acid Amplification System
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 Class II (moderate risk, special controls required), regulated under 21 CFR §862.2570 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Real Time Nucleic Acid Amplification System LIGHT-BOOK · MAUDE
#429 of 1000 · 2,746 reports · 2011–2026
- BOOK 2,746 reports
- RANK #429 of 1000
- DEATH 0 death-typed
- INJ 23 injury-typed
- MALF 2,717 malfunction
- SPAN 2011–2026
- PEAK 2022: 874
- PHOTO Prosthesis, Penile
Nearest event-volume peer: Prosthesis, Penile (8 report gap)
Real Time Nucleic Acid Amplification System sits #429 of 1000 among tracked device types with 2,746 MAUDE reports spanning 2011–2026. 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
Real Time Nucleic Acid Amplification System carries 98.9% MALFUNCTION-coded reports, 34.1pp 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 0.8% corpus 30.3% · below corpus mean (-29.5 pp)
- MALF 98.9% corpus 64.8% · above corpus mean (+34.1 pp)
Lead product-problem code False Positive Result is 44% of coded problems · Lead manufacturer BECTON, DICKINSON & CO. (SPARKS) accounts for 86% of manufacturer-tagged reports · Top event location is 92% of location-tagged rows .
Real Time Nucleic Acid Amplification System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Radioimmunoas…
Radioimmunoassay, Thyroid-Stimulating Hormone
2,771 reports
- Separator
Separator, Automated, Blood Cell And Plasma, Therapeutic
2,769 reports
- Prosthesis
Prosthesis, Penile
2,754 reports
- Real Time Nuc… (this)
Real Time Nucleic Acid Amplification System
2,746 reports
- System
System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
2,731 reports
- Drills
Drills, Burrs, Trephines & Accessories (Compound, Powered)
2,726 reports
What this shows Real Time Nucleic Acid Amplification System carries 2,746 MAUDE reports, ranked #429 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 533 in 2025, up from an average of 274 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Real Time Nucleic Acid Amplification System
Top Manufacturers
Event Locations
Compare BECTON, DICKINSON & CO. (SPARKS) vs BECTON, DICKINSON & CO. →
Nationwide devices with a comparable report-volume footprint
Real Time Nucleic Acid Amplification System 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 (2,746 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Real Time Nucleic Acid Amplification System 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 Real Time Nucleic Acid Amplification System; 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.