System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic 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 System LIGHT-BOOK · MAUDE
#380 of 1000 · 3,131 reports · 2007–2026
- BOOK 3,131 reports
- RANK #380 of 1000
- DEATH 0 death-typed
- INJ 49 injury-typed
- MALF 3,071 malfunction
- SPAN 2007–2026
- PEAK 2012: 1,785
- PHOTO Scaler, Ultrasonic
Nearest event-volume peer: Scaler, Ultrasonic (3 report gap)
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer sits #380 of 1000 among tracked device types with 3,131 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 1.6% corpus 30.4% · below corpus mean (-28.9 pp)
- MALF 98.1% corpus 64.5% · above corpus mean (+33.6 pp)
Lead product-problem code High Test Results is 65% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 72% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .
System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Accessories
Accessories, Implant, Dental, Endosseous
3,152 reports
- Catheter
Catheter, Hemodialysis, Non-Implanted
3,144 reports
- Scaler
Scaler, Ultrasonic
3,134 reports
- System (this)
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
3,131 reports
- Apparatus
Apparatus, Autotransfusion
3,115 reports
- Unit
Unit, Cryosurgical, Accessories
3,107 reports
What this shows System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer carries 3,131 MAUDE reports, ranked #380 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
Related Entities for System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for System, 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 (3,131 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 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 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.