2026 data FDA MAUDE openFDA

Total, Prostate Specific Antigen (Noncomplexed & Complexed) 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.

FDA MAUDE casebook

openFDA event book Total LIGHT-BOOK · MAUDE

#866 of 1000 · 505 reports · 2007–2026

  • BOOK 505 reports
  • RANK #866 of 1000
  • DEATH 0 death-typed
  • INJ 17 injury-typed
  • MALF 481 malfunction
  • SPAN 2007–2026
  • PEAK 2013: 89
  • PHOTO Cutter, Wire

Nearest event-volume peer: Cutter, Wire (0 report gap)

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer sits #866 of 1000 among tracked device types with 505 MAUDE reports spanning 2007–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 3.4% corpus 30.4% · below corpus mean (-27.1 pp)
  • MALF 95.2% corpus 64.5% · above corpus mean (+30.7 pp)

Lead product-problem code High Test Results is 39% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 49% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Total in the event-volume neighbourhood

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

reports

What this shows Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer carries 505 MAUDE reports, ranked #866 of 1000.

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

Event Types

Malfunction 481 (95.2%)
Injury 17 (3.4%)
Other 7 (1.4%)

Patient Outcomes

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

486 (96.4%)
Other 15 (3.0%)
Disability 2 (0.4%)
Required Intervention 1 (0.2%)

Top Product Problems

High Test Results 156
Low Test Results 102
Incorrect Measurement 33
Non Reproducible Results 29
Adverse Event Without Identified Device or Use Problem 22
Incorrect, Inadequate or Imprecise Result or Readings 20
Device Ingredient or Reagent Problem 15
Incorrect Or Inadequate Test Results 6
No Apparent Adverse Event 4
Output Problem 4
Insufficient Information 2
Failure to Calibrate 1
High Readings 1
Leak/Splash 1
Low Readings 1
No Device Output 1
Signal Artifact/Noise 1
Unable to Obtain Readings 1

Yearly Trend

07
2007: 1
08
2008: 4
09
2009: 3
10
2010: 5
11
2011: 10
12
2012: 17
13
2013: 89
14
2014: 12
15
2015: 17
16
2016: 16
17
2017: 39
18
2018: 30
19
2019: 21
20
2020: 14
21
2021: 46
22
2022: 45
23
2023: 29
24
2024: 31
25
2025: 66
26
2026: 10

Related Entities for Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

Event Locations

306 (60.6%)
I 165 (32.7%)
LABORATORY 34 (6.7%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Total, 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 (505 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 Total 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 Total; 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.