2026 data FDA MAUDE openFDA

Fluorometer, 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 MAUDE casebook

openFDA event book Fluorometer, For Clinical Use LIGHT-BOOK · MAUDE

#333 of 1000 · 4,438 reports · 1998–2026

  • BOOK 4,438 reports
  • RANK #333 of 1000
  • DEATH 0 death-typed
  • INJ 23 injury-typed
  • MALF 4,400 malfunction
  • SPAN 1998–2026
  • PEAK 2018: 2,123
  • PHOTO Closed Antineoplastic…

Nearest event-volume peer: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System (7 report gap)

Fluorometer, For Clinical Use sits #333 of 1000 among tracked device types with 4,438 MAUDE reports spanning 1998–2026. 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 0.5% corpus 30.4% · below corpus mean (-29.9 pp)
  • MALF 99.1% corpus 64.5% · above corpus mean (+34.6 pp)

Lead product-problem code Mechanical Problem is 28% of coded problems · Lead manufacturer TOSOH CORPORATION accounts for 88% of manufacturer-tagged reports · Top event location OUTPATIENT DIAGNOSTIC FACILITY is 45% of location-tagged rows .

Fluorometer, For Clinical Use in the event-volume neighbourhood

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

reports

What this shows Fluorometer, For Clinical Use carries 4,438 MAUDE reports, ranked #333 of 1000.

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

Event Types

Malfunction 4,400 (99.1%)
Injury 23 (0.5%)
Other 14 (0.3%)
1 (0.0%)

Patient Outcomes

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

4,331 (97.6%)
Other 46 (1.0%)
Death 18 (0.4%)
Disability 17 (0.4%)
Required Intervention 13 (0.3%)
Congenital Anomaly 5 (0.1%)
Hospitalization 4 (0.1%)
O 1 (0.0%)
S 1 (0.0%)

Top Product Problems

Mechanical Problem 1,372
Device Displays Incorrect Message 878
Device Operates Differently Than Expected 632
Device Operational Issue 542
Incorrect, Inadequate or Imprecise Result or Readings 470
Device Issue 371
Imprecision 74
Incorrect Or Inadequate Test Results 71
Electrical /Electronic Property Problem 64
Failure to Align 63
Output Problem 59
High Test Results 57
Maintenance Does Not Comply To Manufacturers Recommendations 48
False Reading From Device Non-Compliance 47
High Readings 46
Obstruction of Flow 40
Leak/Splash 31
Low Test Results 29
Noise, Audible 27
Low Readings 26

Yearly Trend

98
1998: 3
99
1999: 4
00
2000: 2
03
2003: 3
04
2004: 8
05
2005: 11
06
2006: 10
07
2007: 5
08
2008: 1
09
2009: 24
10
2010: 49
11
2011: 29
12
2012: 68
13
2013: 53
14
2014: 65
15
2015: 30
16
2016: 35
17
2017: 152
18
2018: 2,123
19
2019: 440
20
2020: 257
21
2021: 213
22
2022: 224
23
2023: 260
24
2024: 168
25
2025: 181
26
2026: 20

Related Entities for Fluorometer, For Clinical Use

Top Manufacturers

Event Locations

OUTPATIENT DIAGNOSTIC FACILITY 1,980 (44.6%)
1,244 (28.0%)
I 1,032 (23.3%)
HOSPITAL 68 (1.5%)
OUTPATIENT TREATMENT FACILITY 63 (1.4%)
OTHER 42 (0.9%)
NO INFORMATION 6 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
HOME 1 (0.0%)
NURSING HOME 1 (0.0%)

Compare TOSOH CORPORATION vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Fluorometer, 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 (4,438 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Fluorometer, 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 Fluorometer, 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.