PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

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 §862.1340 (Clinical Chemistry panel).

Browse devices → Device safety hub

FDA MAUDE casebook

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

#861 of 1000 · 547 reports · 1994–2026

  • BOOK 547 reports
  • RANK #861 of 1000
  • DEATH 0 death-typed
  • INJ 15 injury-typed
  • MALF 464 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 68
  • PHOTO Computer

Nearest event-volume peer: Computer, Blood-Pressure (1 report gap)

Method, Enzymatic, Glucose (Urinary, Non-Quantitative) sits #861 of 1000 among tracked device types with 547 MAUDE reports spanning 1994–2026. 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 →

Injury-coded reports sit below the device-type norm

Method, Enzymatic, Glucose carries 2.7% INJURY-coded reports, 27.6pp below 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 2.7% corpus 30.3% · below corpus mean (-27.6 pp)
  • MALF 84.8% corpus 64.8% · above corpus mean (+20.0 pp)

Lead product-problem code False Negative Result is 33% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 75% of manufacturer-tagged reports · Top event location I is 46% of location-tagged rows .

Method, Enzymatic, Glucose in the event-volume neighbourhood

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

reports

What this shows Method, Enzymatic, Glucose (Urinary, Non-Quantitative) carries 547 MAUDE reports, ranked #861 of 1000.

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

Event Types

Malfunction 464 (84.8%)
41 (7.5%)
Other 27 (4.9%)
Injury 15 (2.7%)

Patient Outcomes

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

529 (96.9%)
Required Intervention 8 (1.5%)
Hospitalization 4 (0.7%)
Other 4 (0.7%)
O 1 (0.2%)

Top Product Problems

False Negative Result 180
Low Test Results 56
Smoking 47
False Positive Result 40
High Test Results 34
Incorrect, Inadequate or Imprecise Result or Readings 30
Electrical /Electronic Property Problem 26
Incorrect Or Inadequate Test Results 24
Break 23
Nonstandard Device 22
Non Reproducible Results 13
Patient Data Problem 8
Missing Information 6
Use of Device Problem 6
Data Problem 5
Device Emits Odor 4
Device Markings/Labelling Problem 4
Device Operates Differently Than Expected 4
Power Problem 4
Replace 4

Yearly Trend

94
1994: 2
97
1997: 2
00
2000: 1
03
2003: 3
04
2004: 1
05
2005: 1
06
2006: 2
07
2007: 20
08
2008: 20
09
2009: 16
10
2010: 11
11
2011: 14
12
2012: 5
13
2013: 32
14
2014: 47
15
2015: 45
16
2016: 40
17
2017: 33
18
2018: 68
19
2019: 67
20
2020: 23
21
2021: 12
22
2022: 14
23
2023: 15
24
2024: 21
25
2025: 16
26
2026: 16

Reports in 2025 (16) held close to the prior two-year average of 18.

Related Entities for Method, Enzymatic, Glucose (Urinary, Non-Quantitative)

Top Manufacturers

ROCHE DIAGNOSTICS 232
SIEMENS HEALTHCARE DIAGNOSTICS INC. 65
SIEMENS HEALTHCARE DIAGNOSTICS INC 10
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 4

Event Locations

I 254 (46.4%)
192 (35.1%)
OTHER 57 (10.4%)
LABORATORY 22 (4.0%)
HOSPITAL 8 (1.5%)
U 4 (0.7%)
NO INFORMATION 3 (0.5%)
UNKNOWN 2 (0.4%)
AMBULATORY HEALTH CARE FACILITY 1 (0.2%)
EMERGENCY ROOM 1 (0.2%)
HOME 1 (0.2%)
INVALID DATA 1 (0.2%)
NOT APPLICABLE 1 (0.2%)

Compare ROCHE DIAGNOSTICS vs SIEMENS HEALTHCARE DIAGNOSTICS INC. →

Nationwide devices with a comparable report-volume footprint

Method, Enzymatic, Glucose 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 (547 here).

Computer, Blood-Pressure 546 Kit, Surgical Instrument, Disposable 550 Collector, Ostomy 543 Applicator, Absorbent Tipped, Non-Sterile 552

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 Method, Enzymatic, Glucose 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 Method, Enzymatic, Glucose; 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.