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2026 data FDA MAUDE openFDA FDA Class II

Enzyme Immunoassay, Diphenylhydantoin

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 §862.3350 (Clinical Toxicology panel).

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FDA MAUDE casebook

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

#691 of 1000 · 905 reports · 1998–2026

  • BOOK 905 reports
  • RANK #691 of 1000
  • DEATH 0 death-typed
  • INJ 2 injury-typed
  • MALF 902 malfunction
  • SPAN 1998–2026
  • PEAK 2013: 163
  • PHOTO Passer

Nearest event-volume peer: Passer (1 report gap)

Enzyme Immunoassay, Diphenylhydantoin sits #691 of 1000 among tracked device types with 905 MAUDE reports spanning 1998–2026. 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, Diphenylhydantoin carries 99.7% MALFUNCTION-coded reports, 34.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 0.2% corpus 30.3% · below corpus mean (-30.1 pp)
  • MALF 99.7% corpus 64.8% · above corpus mean (+34.8 pp)

Lead product-problem code Low Test Results is 27% of coded problems · Lead manufacturer ORTHO-CLINICAL DIAGNOSTICS accounts for 97% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Enzyme Immunoassay, Diphenylhydantoin in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Enzyme Immunoassay, Diphenylhydantoin carries 905 MAUDE reports, ranked #691 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 902 (99.7%)
Injury 2 (0.2%)
Other 1 (0.1%)

Patient Outcomes

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

900 (99.3%)
Other 2 (0.2%)
R 1 (0.1%)
Death 1 (0.1%)
Hospitalization 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Low Test Results 304
Incorrect Or Inadequate Test Results 298
High Test Results 292
Incorrect, Inadequate or Imprecise Result or Readings 87
No Apparent Adverse Event 42
Nonstandard Device 17
False Negative Result 15
High Readings 8
Other (for use when an appropriate device code cannot be identified) 8
Low Readings 7
Failure to Calibrate 6
Imprecision 6
Unexpected Therapeutic Results 6
Calibration Error 3
Device Operates Differently Than Expected 3
Failure to Recalibrate 3
Non Reproducible Results 3
False Reading From Device Non-Compliance 2
Use of Incorrect Control/Treatment Settings 2
Device Alarm System 1

Yearly Trend

98
1998: 2
04
2004: 1
05
2005: 4
06
2006: 1
07
2007: 2
08
2008: 20
09
2009: 10
10
2010: 59
11
2011: 104
12
2012: 51
13
2013: 163
14
2014: 57
15
2015: 65
16
2016: 69
17
2017: 55
18
2018: 79
19
2019: 25
20
2020: 17
21
2021: 49
22
2022: 18
23
2023: 42
24
2024: 5
25
2025: 2
26
2026: 5

Reports fell to 2 in 2025, down from an average of 24 in the two years before.

Related Entities for Enzyme Immunoassay, Diphenylhydantoin

Top Manufacturers

ORTHO-CLINICAL DIAGNOSTICS 796
ROCHE DIAGNOSTICS 12
ABBOTT MANUFACTURING, INC. 9
ABBOTT LABORATORIES 2
ORTHO CLINICAL DIAGNOSTICS 1

Event Locations

588 (65.0%)
I 303 (33.5%)
LABORATORY 7 (0.8%)
NO INFORMATION 4 (0.4%)
NOT APPLICABLE 2 (0.2%)
HOSPITAL 1 (0.1%)

Compare ORTHO-CLINICAL DIAGNOSTICS vs ROCHE DIAGNOSTICS →

Nationwide devices with a comparable report-volume footprint

Enzyme Immunoassay, Diphenylhydantoin 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 (905 here).

Passer 906 Device 909 Implant, Fixation Device, Spinal 909 Appliance 910

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, Diphenylhydantoin 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, Diphenylhydantoin; 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.