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2026 data FDA MAUDE openFDA

Diazo Colorimetry, Bilirubin

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.

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FDA MAUDE casebook

openFDA event book Diazo Colorimetry, Bilirubin LIGHT-BOOK · MAUDE

#969 of 1000 · 375 reports · 1999–2026

  • BOOK 375 reports
  • RANK #969 of 1000
  • DEATH 0 death-typed
  • INJ 4 injury-typed
  • MALF 367 malfunction
  • SPAN 1999–2026
  • PEAK 2025: 53
  • PHOTO Device

Nearest event-volume peer: Device, Percutaneous Retrieval (1 report gap)

Diazo Colorimetry, Bilirubin sits #969 of 1000 among tracked device types with 375 MAUDE reports spanning 1999–2026. 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 →

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 1.1% corpus 30.4% · below corpus mean (-29.4 pp)
  • MALF 97.9% corpus 64.5% · above corpus mean (+33.4 pp)

Lead product-problem code High Test Results is 40% of coded problems · Lead manufacturer ABBOTT GMBH accounts for 31% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Diazo Colorimetry, Bilirubin in the event-volume neighbourhood

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

reports

What this shows Diazo Colorimetry, Bilirubin carries 375 MAUDE reports, ranked #969 of 1000.

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

Event Types

Malfunction 367 (97.9%)
Injury 4 (1.1%)
Other 4 (1.1%)

Patient Outcomes

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

359 (95.7%)
Other 9 (2.4%)
Congenital Anomaly 3 (0.8%)
O 1 (0.3%)
Death 1 (0.3%)
Life Threatening 1 (0.3%)
Required Intervention 1 (0.3%)

Top Product Problems

High Test Results 121
Low Test Results 115
Non Reproducible Results 27
Incorrect, Inadequate or Imprecise Result or Readings 15
Incorrect Or Inadequate Test Results 5
High Readings 3
Insufficient Information 3
Incorrect Measurement 2
Output Problem 2
Patient-Device Incompatibility 2
Unable to Obtain Readings 2
Application Program Problem 1
Chemical Problem 1
Device Ingredient or Reagent Problem 1
False Negative Result 1
False Positive Result 1
Use of Device Problem 1

Yearly Trend

99
1999: 1
00
2000: 1
01
2001: 1
02
2002: 1
05
2005: 1
06
2006: 1
07
2007: 2
08
2008: 8
09
2009: 3
10
2010: 6
11
2011: 38
12
2012: 14
13
2013: 8
14
2014: 3
15
2015: 7
16
2016: 4
17
2017: 11
18
2018: 23
19
2019: 25
20
2020: 31
21
2021: 22
22
2022: 26
23
2023: 34
24
2024: 39
25
2025: 53
26
2026: 12

Related Entities for Diazo Colorimetry, Bilirubin

Top Manufacturers

ABBOTT GMBH 96
ROCHE DIAGNOSTICS 91
ABBOTT MANUFACTURING INC 45
ABBOTT LABORATORIES 26
BECKMAN COULTER, INC. 22
ORTHO-CLINICAL DIAGNOSTICS 13
ABBOTT MANUFACTURING, INC. 11
SIEMENS HEALTHCARE DIAGNOSTICS INC. 10

Event Locations

236 (62.9%)
I 116 (30.9%)
LABORATORY 15 (4.0%)
NO INFORMATION 3 (0.8%)
NOT APPLICABLE 3 (0.8%)
HOSPITAL 1 (0.3%)
OTHER 1 (0.3%)

Compare ABBOTT GMBH vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Diazo Colorimetry, Bilirubin, 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 (375 here).

Device, Percutaneous Retrieval 374 Polymer Patient Examination Glove 376 Alkaline Picrate, Colorimetry, Creatinine 372 Scissors, Ophthalmic 378

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 Diazo Colorimetry, Bilirubin 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 Diazo Colorimetry, Bilirubin; 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.