What are FDA adverse event reports for Enzyme Immunoassay, Phenobarbital?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Enzyme Immunoassay, Phenobarbital, there are 403 total reports including 0 death reports and 0 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Enzyme Immunoassay, Phenobarbital?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2024 data FDA MAUDE openFDA

Enzyme Immunoassay, Phenobarbital

Name: Enzyme Immunoassay, Phenobarbital - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Enzyme Immunoassay, Phenobarbital LIGHT-BOOK · MAUDE

#949 of 1000 · 403 reports · 2001–2024

BOOK 403 reports
RANK #949 of 1000
DEATH 0 death-typed
INJ 0 injury-typed
MALF 403 malfunction
SPAN 2001–2024
PEAK 2012: 222
PHOTO Cable, Electrode

Nearest event-volume peer: Cable, Electrode (0 report gap)

Enzyme Immunoassay, Phenobarbital sits #949 of 1000 among tracked device types with 403 MAUDE reports spanning 2001–2024. 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 0.0% corpus 30.4% · below corpus mean (-30.4 pp)
MALF 100.0% corpus 64.5% · above corpus mean (+35.5 pp)

Lead product-problem code Low Test Results is 64% of coded problems · Lead manufacturer ORTHO-CLINICAL DIAGNOSTICS accounts for 96% of manufacturer-tagged reports · Top event location is 99% of location-tagged rows .

Camera

404
Modular Elect…

404
Enzyme Immuno… (this)

403
Cable

403
Condom

402
Methyl Methac…

402

What this shows Enzyme Immunoassay, Phenobarbital carries 403 MAUDE reports, ranked #949 of 1000.

Event Types

Malfunction 403 (100.0%)

Patient Outcomes

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

403 (100.0%)

Yearly Trend

2001: 1

2004: 1

2005: 1

2006: 8

2007: 3

2011: 58

2012: 222

2013: 101

2023: 7

2024: 1

Top Manufacturers

ORTHO-CLINICAL DIAGNOSTICS 366

ABBOTT MANUFACTURING, INC. 7

SIEMENS HEALTHCARE DIAGNOSTICS INC 5

BECKMAN COULTER, INC. 1

SIEMENS HEALTHCARE DIAGNOSTICS INC. 1

Event Locations

400 (99.3%)

NOT APPLICABLE 2 (0.5%)

I 1 (0.2%)

Compare ORTHO-CLINICAL DIAGNOSTICS vs ABBOTT MANUFACTURING, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Enzyme Immunoassay, Phenobarbital, 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 (403 here).

Cable, Electrode 403 Camera, Scintillation 404 Condom 402 Methyl Methacrylate For Cranioplasty 402

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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.

Enzyme Immunoassay, Phenobarbital

Event-type mix vs corpus