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2026 data FDA MAUDE openFDA

Automated Urinalysis System

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 Automated Urinalysis System LIGHT-BOOK · MAUDE

#638 of 1000 · 1,080 reports · 2002–2026

  • BOOK 1,080 reports
  • RANK #638 of 1000
  • DEATH 1 death-typed
  • INJ 24 injury-typed
  • MALF 897 malfunction
  • SPAN 2002–2026
  • PEAK 2016: 373
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Suction, Patient Care (1 report gap)

Automated Urinalysis System sits #638 of 1000 among tracked device types with 1,080 MAUDE reports spanning 2002–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 2.2% corpus 30.4% · below corpus mean (-28.2 pp)
  • MALF 83.1% corpus 64.5% · above corpus mean (+18.5 pp)

Lead product-problem code Device Operates Differently Than Expected is 26% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 65% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Automated Urinalysis System in the event-volume neighbourhood

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

reports

What this shows Automated Urinalysis System carries 1,080 MAUDE reports, ranked #638 of 1000.

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

Event Types

Malfunction 897 (83.1%)
Other 98 (9.1%)
60 (5.6%)
Injury 24 (2.2%)
Death 1 (0.1%)

Patient Outcomes

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

1,032 (95.5%)
Other 41 (3.8%)
Required Intervention 3 (0.3%)
Death 2 (0.2%)
Hospitalization 2 (0.2%)
R 1 (0.1%)

Top Product Problems

Device Operates Differently Than Expected 156
Incorrect, Inadequate or Imprecise Result or Readings 139
False Negative Result 100
Leak/Splash 43
Output Problem 20
False Positive Result 19
High Test Results 18
Device Operational Issue 14
Non Reproducible Results 13
Electrical /Electronic Property Problem 12
Incorrect Or Inadequate Test Results 11
Patient Data Problem 11
Fluid/Blood Leak 9
Low Test Results 9
Thermal Decomposition of Device 8
Incorrect Measurement 6
Computer Software Problem 5
Computer Operating System Problem 4
Fire 4
Smoking 4

Yearly Trend

02
2002: 2
03
2003: 1
05
2005: 7
06
2006: 10
07
2007: 1
08
2008: 4
09
2009: 9
10
2010: 3
11
2011: 8
12
2012: 15
13
2013: 92
14
2014: 106
15
2015: 238
16
2016: 373
17
2017: 20
18
2018: 25
19
2019: 64
20
2020: 21
21
2021: 13
22
2022: 15
23
2023: 19
24
2024: 20
25
2025: 12
26
2026: 2

Related Entities for Automated Urinalysis System

Top Manufacturers

ROCHE DIAGNOSTICS 123
SIEMENS HEALTHCARE DIAGNOSTICS INC. 46
SIEMENS HEALTHCARE DIAGNOSTICS INC 20

Event Locations

I 600 (55.6%)
444 (41.1%)
NO INFORMATION 15 (1.4%)
OTHER 9 (0.8%)
NOT APPLICABLE 6 (0.6%)
HOSPITAL 3 (0.3%)
LABORATORY 3 (0.3%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Automated Urinalysis System, 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 (1,080 here).

Apparatus, Suction, Patient Care 1,081 Introducer, Syringe Needle 1,076 Instrument 1,086 Laryngoscope, Non-Rigid 1,074

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Automated Urinalysis System 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 Automated Urinalysis System; 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.