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2023 data FDA MAUDE openFDA FDA Class III

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

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 Multi-Analyte Test System With Algorithmic… LIGHT-BOOK · MAUDE

#992 of 1000 · 371 reports · 2023–2023

  • BOOK 371 reports
  • RANK #992 of 1000
  • DEATH 0 death-typed
  • INJ 0 injury-typed
  • MALF 371 malfunction
  • SPAN 2023–2023
  • PEAK 2023: 371
  • PHOTO Antigens

Nearest event-volume peer: Antigens, All Groups, Streptococcus Spp. (1 report gap)

Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer sits #992 of 1000 among tracked device types with 371 MAUDE reports spanning 2023–2023. 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 →

Malfunction reports run above the device-type norm

Multi-Analyte Test System With Algorithmic… carries 100.0% MALFUNCTION-coded reports, 35.2pp 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 0.0% corpus 30.3% · below corpus mean (-30.3 pp)
  • MALF 100.0% corpus 64.8% · above corpus mean (+35.2 pp)

Lead product-problem code Application Program Version or Upgrade Problem is 100% of coded problems · Top event location is 100% of location-tagged rows .

Multi-Analyte Test System With Algorithmic… in the event-volume neighbourhood

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

reports

What this shows Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer carries 371 MAUDE reports, ranked #992 of 1000.

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

Event Types

Malfunction 371 (100.0%)

Patient Outcomes

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

Other 371 (100.0%)

Top Product Problems

Application Program Version or Upgrade Problem 371

Yearly Trend

23
2023: 371

Related Entities for Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

Event Locations

371 (100.0%)

Nationwide devices with a comparable report-volume footprint

Multi-Analyte Test System With Algorithmic… 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 (371 here).

Antigens, All Groups, Streptococcus Spp. 370 Azo Dye, Calcium 372 Lens, Contact, 372 Photometric Method, Magnesium 370

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 Multi-Analyte Test System With Algorithmic… 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 Multi-Analyte Test System With Algorithmic…; 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.