What are FDA adverse event reports for Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use, there are 354 total reports including 2 death reports and 20 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 Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use?

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.

2015 data FDA MAUDE openFDA

Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use

Name: Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use - 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 Analyzer, Chemistry Clinical Use LIGHT-BOOK · MAUDE

#989 of 1000 · 354 reports · 1993–2015

BOOK 354 reports
RANK #989 of 1000
DEATH 2 death-typed
INJ 20 injury-typed
MALF 264 malfunction
SPAN 1993–2015
PEAK 2009: 62
PHOTO Mediastinoscope

Nearest event-volume peer: Mediastinoscope, Surgical (1 report gap)

Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use sits #989 of 1000 among tracked device types with 354 MAUDE reports spanning 1993–2015. 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 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
INJ 5.6% corpus 30.4% · below corpus mean (-24.8 pp)
MALF 74.6% corpus 64.5% · above corpus mean (+10.1 pp)

Lead manufacturer BECKMAN COULTER INC. accounts for 45% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Antigens

356
System

356
Mediastinosco…

355
Analyzer (this)

354
Catheter

352
Microscope

352

What this shows Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use carries 354 MAUDE reports, ranked #989 of 1000.

Event Types

Malfunction 264 (74.6%)

Other 56 (15.8%)

Injury 20 (5.6%)

12 (3.4%)

Death 2 (0.6%)

Patient Outcomes

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

263 (73.5%)

Other 71 (19.8%)

Hospitalization 10 (2.8%)

Required Intervention 7 (2.0%)

O 2 (0.6%)

Death 2 (0.6%)

L 1 (0.3%)

R 1 (0.3%)

Life Threatening 1 (0.3%)

Yearly Trend

1993: 2

1994: 6

1995: 2

1996: 11

1997: 34

1998: 8

1999: 5

2000: 13

2001: 3

2002: 7

2003: 9

2004: 26

2005: 31

2006: 34

2007: 8

2008: 4

2009: 62

2010: 41

2011: 22

2012: 3

2013: 8

2014: 8

2015: 7

Top Manufacturers

BECKMAN COULTER INC. 102

ROCHE DIAGNOSTICS 53

BECKMAN COULTER, INC. 48

ABBOTT MANUFACTURING, INC. 16

ABBOTT MANUFACTURING INC 6

Event Locations

223 (63.0%)

HOSPITAL 42 (11.9%)

LABORATORY 30 (8.5%)

OTHER 21 (5.9%)

INVALID DATA 14 (4.0%)

NOT APPLICABLE 9 (2.5%)

UNKNOWN 6 (1.7%)

OUTPATIENT DIAGNOSTIC FACILITY 5 (1.4%)

OUTPATIENT TREATMENT FACILITY 2 (0.6%)

HOME 1 (0.3%)

LABORATORY/PATHOLOGY DEPARTMENT 1 (0.3%)

Compare BECKMAN COULTER INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Analyzer, Chemistry Clinical Use, 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 (354 here).

Mediastinoscope, Surgical 355 Antigens, All Groups, Streptococcus Spp. 356 Catheter, Ureteral, Gastro-Urology 352 Microscope 352

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Analyzer, Chemistry Clinical Use 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 Analyzer, Chemistry Clinical Use; 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.