Enzyme Immunoassay, Digoxin
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 §862.3320 (Clinical Toxicology panel).
FDA MAUDE casebook
openFDA event book Enzyme Immunoassay, Digoxin LIGHT-BOOK · MAUDE
#908 of 1000 · 478 reports · 1994–2026
- BOOK 478 reports
- RANK #908 of 1000
- DEATH 1 death-typed
- INJ 5 injury-typed
- MALF 462 malfunction
- SPAN 1994–2026
- PEAK 2007: 310
- PHOTO Scaffold
Nearest event-volume peer: Scaffold, Dissection Repair (0 report gap)
Enzyme Immunoassay, Digoxin sits #908 of 1000 among tracked device types with 478 MAUDE reports spanning 1994–2026. 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
Enzyme Immunoassay, Digoxin carries 96.7% MALFUNCTION-coded reports, 31.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
- INJ 1.0% corpus 30.3% · below corpus mean (-29.2 pp)
- MALF 96.7% corpus 64.8% · above corpus mean (+31.8 pp)
Lead product-problem code Device Displays Incorrect Message is 48% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 37% of manufacturer-tagged reports · Top event location is 89% of location-tagged rows .
Enzyme Immunoassay, Digoxin in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Cardiac Cathe…
Cardiac Catheterization Kit
481 reports
- Enzyme Immuno… (this)
Enzyme Immunoassay, Digoxin
478 reports
- Scaffold
Scaffold, Dissection Repair
478 reports
- Agents
Agents, Embolic, For Treatment Of Uterine Fibroids
477 reports
- Nucleic-Acid…
Nucleic-Acid Tests Used For Infectious Disease Screening Of Blood And Plasma Donations
475 reports
- Heart-Valve
Heart-Valve, Allograft
474 reports
What this shows Enzyme Immunoassay, Digoxin carries 478 MAUDE reports, ranked #908 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 7 in 2024, up from an average of 4 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Enzyme Immunoassay, Digoxin
Top Manufacturers
Event Locations
Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Enzyme Immunoassay, Digoxin: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (478 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Enzyme Immunoassay, Digoxin 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 Enzyme Immunoassay, Digoxin; 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.