2026 data FDA MAUDE openFDA FDA Class I

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.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §862.2160 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book Analyzer, Chemistry, For Clinical Use MID-BOOK · MAUDE

#48 of 1000 · 78,872 reports · 1996–2026

  • BOOK 78,872 reports
  • RANK #48 of 1000
  • DEATH 25 death-typed
  • INJ 1,167 injury-typed
  • MALF 75,298 malfunction
  • SPAN 1996–2026
  • PEAK 2011: 11,605
  • PHOTO Intraocular Lens

Nearest event-volume peer: Intraocular Lens (486 report gap)

Analyzer, Chemistry (Photometric, Discrete), For Clinical Use sits #48 of 1000 among tracked device types with 78,872 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 →

Malfunction reports run above the device-type norm

Analyzer, Chemistry, For Clinical Use carries 95.5% MALFUNCTION-coded reports, 30.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.5% corpus 30.3% · below corpus mean (-28.8 pp)
  • MALF 95.5% corpus 64.8% · above corpus mean (+30.6 pp)

Lead product-problem code High Test Results is 26% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 37% of manufacturer-tagged reports · Top event location is 64% 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 78,872 MAUDE reports, ranked #48 of 1000.

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

Event Types

Malfunction 75,298 (95.5%)
Other 2,018 (2.6%)
Injury 1,167 (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.

75,852 (97.0%)
Other 1,698 (2.2%)
Required Intervention 304 (0.4%)
Hospitalization 148 (0.2%)
Disability 54 (0.1%)
O 43 (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 2 (0.0%)

Top Product Problems

High Test Results 21,337
Low Test Results 19,313
Incorrect Or Inadequate Test Results 9,496
Non Reproducible Results 7,394
Incorrect, Inadequate or Imprecise Result or Readings 6,979
Fluid/Blood Leak 2,859
Leak/Splash 2,488
Device Displays Incorrect Message 2,186
False Positive Result 2,040
Mechanical Problem 1,885
False Negative Result 900
Adverse Event Without Identified Device or Use Problem 862
Incorrect Measurement 772
Smoking 736
Device Operates Differently Than Expected 618
Repair 580
Patient Data Problem 496
Nonstandard Device 488
Output Problem 405
Computer Software Problem 326

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: 3,439
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: 4,470
26
2026: 2,777

Reports in 2025 (4,470) held close to the prior two-year average of 4,002.

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

Event Locations

50,382 (63.9%)
I 20,711 (26.3%)
OTHER 3,639 (4.6%)
LABORATORY 3,467 (4.4%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Analyzer, Chemistry, For Clinical Use: 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 (78,872 here).

Similar death-typed counts

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

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.