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 Class II (moderate risk, special controls required), regulated under 21 CFR §866.6010 (Immunology panel).
FDA MAUDE casebook
openFDA event book System LIGHT-BOOK · MAUDE
#389 of 1000 · 3,190 reports · 2007–2026
- BOOK 3,190 reports
- RANK #389 of 1000
- DEATH 0 death-typed
- INJ 50 injury-typed
- MALF 3,129 malfunction
- SPAN 2007–2026
- PEAK 2012: 1,785
- PHOTO Test, Hiv Detection
Nearest event-volume peer: Test, Hiv Detection (3 report gap)
System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer sits #389 of 1000 among tracked device types with 3,190 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 →
Malfunction reports run above the device-type norm
System carries 98.1% MALFUNCTION-coded reports, 33.3pp 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 1.6% corpus 30.3% · below corpus mean (-28.7 pp)
- MALF 98.1% corpus 64.8% · above corpus mean (+33.3 pp)
Lead product-problem code High Test Results is 54% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 71% 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
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3,214 reports
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3,214 reports
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System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
3,190 reports
- Test
Test, Hiv Detection
3,187 reports
- System
System, Measurement, Blood-Pressure, Non-Invasive
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What this shows System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer carries 3,190 MAUDE reports, ranked #389 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 in 2025 (100) held close to the prior two-year average of 125.
Related Entities for System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
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 (3,190 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.