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.
FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §862.2900 (Clinical Chemistry panel).
FDA MAUDE casebook
openFDA event book Automated Urinalysis System LIGHT-BOOK · MAUDE
#645 of 1000 · 1,086 reports · 2002–2026
- BOOK 1,086 reports
- RANK #645 of 1000
- DEATH 1 death-typed
- INJ 24 injury-typed
- MALF 903 malfunction
- SPAN 2002–2026
- PEAK 2016: 373
- PHOTO Instrument
Nearest event-volume peer: Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment (1 report gap)
Automated Urinalysis System sits #645 of 1000 among tracked device types with 1,086 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 →
Injury-coded reports sit below the device-type norm
Automated Urinalysis System carries 2.2% INJURY-coded reports, 28.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
- INJ 2.2% corpus 30.3% · below corpus mean (-28.1 pp)
- MALF 83.1% corpus 64.8% · above corpus mean (+18.3 pp)
Lead product-problem code Device Operates Differently Than Expected is 28% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 66% of manufacturer-tagged reports · Top event location I is 55% of location-tagged rows .
Automated Urinalysis System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Laryngoscope
Laryngoscope, Non-Rigid
1,099 reports
- Growing Rod S…
Growing Rod System- Magnetic Actuation
1,094 reports
- Instrument
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
1,087 reports
- Automated Uri… (this)
Automated Urinalysis System
1,086 reports
- Introducer
Introducer, Syringe Needle
1,079 reports
- Hemostatic De…
Hemostatic Device For Endoscopic Gastrointestinal Use
1,077 reports
What this shows Automated Urinalysis System carries 1,086 MAUDE reports, ranked #645 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 12 in 2025, down from an average of 20 in the two years before.
Related Entities for Automated Urinalysis System
Top Manufacturers
Event Locations
Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC. →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Automated Urinalysis System: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,086 here).
Similar death-typed counts
Nearest other device types by death-typed report count (1 here), distinct from the volume row.
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.