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2026 data FDA MAUDE openFDA

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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 Analyzer, Chemistry, For Clinical Use MID-BOOK · MAUDE

#47 of 1000 · 76,746 reports · 1996–2026

  • BOOK 76,746 reports
  • RANK #47 of 1000
  • DEATH 25 death-typed
  • INJ 1,133 injury-typed
  • MALF 73,208 malfunction
  • SPAN 1996–2026
  • PEAK 2011: 11,605
  • PHOTO Intraocular Lens

Nearest event-volume peer: Intraocular Lens (272 report gap)

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use sits #47 of 1000 among tracked device types with 76,746 MAUDE reports spanning 1996–2026. 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 1.5% corpus 30.4% · below corpus mean (-29.0 pp)
  • MALF 95.4% corpus 64.5% · above corpus mean (+30.9 pp)

Lead product-problem code High Test Results is 27% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 36% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Analyzer, Chemistry, For Clinical Use in the event-volume neighbourhood

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

reports

What this shows Analyzer, Chemistry (Photometric, Discrete), For Clinical Use carries 76,746 MAUDE reports, ranked #47 of 1000.

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

Event Types

Malfunction 73,208 (95.4%)
Other 2,016 (2.6%)
Injury 1,133 (1.5%)
364 (0.5%)
Death 25 (0.0%)

Patient Outcomes

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

73,898 (97.0%)
Other 1,672 (2.2%)
Required Intervention 297 (0.4%)
Hospitalization 147 (0.2%)
Disability 52 (0.1%)
O 42 (0.1%)
Death 36 (0.0%)
Life Threatening 18 (0.0%)
R 10 (0.0%)
Congenital Anomaly 9 (0.0%)
H 4 (0.0%)
S 3 (0.0%)
L 1 (0.0%)

Top Product Problems

High Test Results 11,390
Low Test Results 10,741
Non Reproducible Results 6,769
Incorrect, Inadequate or Imprecise Result or Readings 5,606
Mechanical Problem 1,592
False Positive Result 829
Incorrect Or Inadequate Test Results 770
Adverse Event Without Identified Device or Use Problem 728
Incorrect Measurement 652
Leak/Splash 410
Patient Data Problem 401
Output Problem 335
Smoking 277
False Negative Result 233
Fluid/Blood Leak 218
Computer Software Problem 187
Insufficient Information 169
Device Issue 152
No Apparent Adverse Event 147
High Readings 136

Yearly Trend

96
1996: 28
97
1997: 104
98
1998: 111
99
1999: 172
00
2000: 127
01
2001: 73
02
2002: 292
03
2003: 447
04
2004: 620
05
2005: 818
06
2006: 1,451
07
2007: 2,181
08
2008: 2,159
09
2009: 3,440
10
2010: 3,273
11
2011: 11,605
12
2012: 3,707
13
2013: 2,489
14
2014: 2,841
15
2015: 2,793
16
2016: 2,580
17
2017: 1,869
18
2018: 4,590
19
2019: 3,948
20
2020: 3,986
21
2021: 3,920
22
2022: 3,998
23
2023: 3,783
24
2024: 4,221
25
2025: 4,451
26
2026: 669

Related Entities for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

Top Manufacturers

ROCHE DIAGNOSTICS 24,843
BECKMAN COULTER, INC. 11,375
BECKMAN COULTER 6,947
SIEMENS HEALTHCARE DIAGNOSTICS INC. 6,587
BECKMAN COULTER INC. 5,031
ABBOTT LABORATORIES 4,798
ORTHO-CLINICAL DIAGNOSTICS 2,987
ABBOTT MANUFACTURING INC 2,712
ABBOTT MANUFACTURING, INC. 1,974
SIEMENS HEALTHCARE DIAGNOSTICS INC 1,722

Event Locations

48,255 (62.9%)
I 20,711 (27.0%)
OTHER 3,640 (4.7%)
LABORATORY 3,467 (4.5%)
NOT APPLICABLE 251 (0.3%)
HOSPITAL 136 (0.2%)
NO INFORMATION 129 (0.2%)
INVALID DATA 112 (0.1%)
LABORATORY/PATHOLOGY DEPARTMENT 17 (0.0%)
OUTPATIENT TREATMENT FACILITY 8 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 7 (0.0%)
UNKNOWN 5 (0.0%)
AMBULATORY SURGICAL FACILITY 3 (0.0%)
AMBULATORY SURGICAL CENTER 1 (0.0%)
HOME 1 (0.0%)
NURSING HOME 1 (0.0%)
U 1 (0.0%)
URGENT CARE CENTER 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs BECKMAN COULTER, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Analyzer, Chemistry, For 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 (76,746 here).

Intraocular Lens 77,018 Orthopedic Manual Surgical Instrument 78,848 Transcervical Contraceptive Tubal Occlusion… 74,358 Glucose Dehydrogenase, Glucose 73,910

Similar death-typed counts

Nearest other device types by death-typed report count (25 here), distinct from the volume row.

Agent 25 Aid, Transfer 25 Appliance 25 Shunt, Portosystemic, Endoprosthesis 25

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

Disclaimer: MAUDE figures for Analyzer, Chemistry, For 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, For 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.