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2026 data FDA MAUDE openFDA FDA Class II

Enzymatic Method, Creatinine

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 II (moderate risk, special controls required), regulated under 21 CFR §862.1225 (Clinical Chemistry panel).

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FDA MAUDE casebook

openFDA event book Enzymatic Method, Creatinine LIGHT-BOOK · MAUDE

#852 of 1000 · 563 reports · 1997–2026

  • BOOK 563 reports
  • RANK #852 of 1000
  • DEATH 0 death-typed
  • INJ 14 injury-typed
  • MALF 548 malfunction
  • SPAN 1997–2026
  • PEAK 2025: 60
  • PHOTO Needle

Nearest event-volume peer: Needle, Suturing, Disposable (4 report gap)

Enzymatic Method, Creatinine sits #852 of 1000 among tracked device types with 563 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 →

Malfunction reports run above the device-type norm

Enzymatic Method, Creatinine carries 97.3% MALFUNCTION-coded reports, 32.5pp 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 2.5% corpus 30.3% · below corpus mean (-27.8 pp)
  • MALF 97.3% corpus 64.8% · above corpus mean (+32.5 pp)

Lead product-problem code High Test Results is 33% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 47% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Enzymatic Method, Creatinine in the event-volume neighbourhood

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

reports

What this shows Enzymatic Method, Creatinine carries 563 MAUDE reports, ranked #852 of 1000.

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

Event Types

Malfunction 548 (97.3%)
Injury 14 (2.5%)
Other 1 (0.2%)

Patient Outcomes

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

536 (96.4%)
Other 14 (2.5%)
Hospitalization 4 (0.7%)
Required Intervention 2 (0.4%)

Top Product Problems

High Test Results 205
Low Test Results 181
Non Reproducible Results 60
Incorrect, Inadequate or Imprecise Result or Readings 43
Incorrect Or Inadequate Test Results 41
No Apparent Adverse Event 20
Adverse Event Without Identified Device or Use Problem 16
High Readings 12
Insufficient Device Problem Information 9
Appropriate Device Problem Term/Code Not Available 6
Output Problem 6
Incorrect Measurement 5
Interference 4
Fluid/Blood Leak 3
Leak/Splash 3
Loose or Intermittent Connection 3
Nonstandard Device 3
Low Readings 2
Programming Issue 2
Chemical Problem 1

Yearly Trend

97
1997: 1
00
2000: 4
01
2001: 1
03
2003: 1
05
2005: 2
07
2007: 1
08
2008: 4
09
2009: 22
10
2010: 22
11
2011: 42
12
2012: 24
13
2013: 39
14
2014: 4
15
2015: 7
16
2016: 16
17
2017: 16
18
2018: 34
19
2019: 56
20
2020: 34
21
2021: 57
22
2022: 9
23
2023: 36
24
2024: 34
25
2025: 60
26
2026: 37

Reports rose to 60 in 2025, up from an average of 35 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Enzymatic Method, Creatinine

Top Manufacturers

ROCHE DIAGNOSTICS 182
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

284 (50.4%)
I 217 (38.5%)
LABORATORY 44 (7.8%)
OTHER 8 (1.4%)
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 a comparable report-volume footprint

Enzymatic Method, Creatinine carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (563 here).

Needle, Suturing, Disposable 559 Device 557 Instrument, Ent Manual Surgical 557 Endoscopic Injection Needle 570

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.