Enzyme Immunoassay, Phenobarbital
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 §862.3660 (Clinical Toxicology panel).
FDA MAUDE casebook
openFDA event book Enzyme Immunoassay, Phenobarbital LIGHT-BOOK · MAUDE
#962 of 1000 · 409 reports · 2001–2026
- BOOK 409 reports
- RANK #962 of 1000
- DEATH 0 death-typed
- INJ 0 injury-typed
- MALF 409 malfunction
- SPAN 2001–2026
- PEAK 2012: 222
- PHOTO Condom
Nearest event-volume peer: Condom (1 report gap)
Enzyme Immunoassay, Phenobarbital sits #962 of 1000 among tracked device types with 409 MAUDE reports spanning 2001–2026. 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, Phenobarbital 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 Incorrect Or Inadequate Test Results is 52% of coded problems · Lead manufacturer ORTHO-CLINICAL DIAGNOSTICS accounts for 96% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .
Enzyme Immunoassay, Phenobarbital in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Manometer
Manometer, Spinal-Fluid
411 reports
- Mass Spectrom…
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
411 reports
- Saliva
Saliva, Artificial
411 reports
- Processor
Processor, Cervical Cytology Slide, Automated
410 reports
- Enzyme Immuno… (this)
Enzyme Immunoassay, Phenobarbital
409 reports
- Condom
Condom
408 reports
What this shows Enzyme Immunoassay, Phenobarbital carries 409 MAUDE reports, ranked #962 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 fell to 1 in 2024, down from an average of 54 in the two years before.
Related Entities for Enzyme Immunoassay, Phenobarbital
Top Manufacturers
Event Locations
Compare ORTHO-CLINICAL DIAGNOSTICS vs ABBOTT MANUFACTURING, INC. →
Nationwide devices with a comparable report-volume footprint
Enzyme Immunoassay, Phenobarbital 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 (409 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 Enzyme Immunoassay, Phenobarbital 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, Phenobarbital; 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.