What are FDA adverse event reports for Enzymatic Method, Creatinine?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Enzymatic Method, Creatinine, there are 533 total reports including 0 death reports and 14 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 Enzymatic Method, Creatinine?

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.

2026 data FDA MAUDE openFDA

Enzymatic Method, Creatinine

Name: Enzymatic Method, Creatinine - 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 Enzymatic Method, Creatinine LIGHT-BOOK · MAUDE

#851 of 1000 · 533 reports · 1997–2026

BOOK 533 reports
RANK #851 of 1000
DEATH 0 death-typed
INJ 14 injury-typed
MALF 518 malfunction
SPAN 1997–2026
PEAK 2025: 61
PHOTO Accessories

Nearest event-volume peer: Accessories, Pump, Infusion (0 report gap)

Enzymatic Method, Creatinine sits #851 of 1000 among tracked device types with 533 MAUDE reports spanning 1997–2026. 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 2.6% corpus 30.4% · below corpus mean (-27.8 pp)
MALF 97.2% corpus 64.5% · above corpus mean (+32.7 pp)

Lead product-problem code Low Test Results is 29% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 45% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Applicator

536
Collector

536
Method

535
Culture Media

534
Enzymatic Met… (this)

533
Accessories

533

What this shows Enzymatic Method, Creatinine carries 533 MAUDE reports, ranked #851 of 1000.

Event Types

Malfunction 518 (97.2%)

Injury 14 (2.6%)

Other 1 (0.2%)

Patient Outcomes

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

513 (96.2%)

Other 14 (2.6%)

Hospitalization 4 (0.8%)

Required Intervention 2 (0.4%)

Yearly Trend

1997: 1

2000: 4

2001: 1

2003: 1

2005: 2

2007: 1

2008: 4

2009: 22

2010: 22

2011: 42

2012: 24

2013: 39

2014: 4

2015: 7

2016: 16

2017: 16

2018: 34

2019: 56

2020: 34

2021: 57

2022: 9

2023: 36

2024: 34

2025: 61

2026: 6

Top Manufacturers

ROCHE DIAGNOSTICS 169

ORTHO-CLINICAL DIAGNOSTICS 123

SIEMENS HEALTHCARE DIAGNOSTICS INC. 37

BECKMAN COULTER INC. 21

SIEMENS HEALTHCARE DIAGNOSTICS INC 13

SIEMENS HEALTHCARE DIAGNOSTICS, INC. 9

Event Locations

254 (47.7%)

I 217 (40.7%)

LABORATORY 44 (8.3%)

OTHER 8 (1.5%)

NOT APPLICABLE 6 (1.1%)

OUTPATIENT TREATMENT FACILITY 2 (0.4%)

INVALID DATA 1 (0.2%)

RADIOLOGY DEPARTMENT 1 (0.2%)

Compare ROCHE DIAGNOSTICS vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Enzymatic Method, Creatinine, 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 (533 here).

Accessories, Pump, Infusion 533 Culture Media 534 Method, Enzymatic, Glucose 535 Applicator, Absorbent Tipped, Non-Sterile 536

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Enzymatic Method, Creatinine 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 Enzymatic Method, Creatinine; 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.

Enzymatic Method, Creatinine

Event-type mix vs corpus