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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#848 of 1000 · 535 reports · 1994–2026

  • BOOK 535 reports
  • RANK #848 of 1000
  • DEATH 0 death-typed
  • INJ 15 injury-typed
  • MALF 452 malfunction
  • SPAN 1994–2026
  • PEAK 2018: 68
  • PHOTO Applicator

Nearest event-volume peer: Applicator, Absorbent Tipped, Non-Sterile (1 report gap)

Method, Enzymatic, Glucose (Urinary, Non-Quantitative) sits #848 of 1000 among tracked device types with 535 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 →

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 2.8% corpus 30.4% · below corpus mean (-27.6 pp)
  • MALF 84.5% corpus 64.5% · above corpus mean (+20.0 pp)

Lead product-problem code False Negative Result is 31% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 76% of manufacturer-tagged reports · Top event location I is 47% 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 535 MAUDE reports, ranked #848 of 1000.

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

Event Types

Malfunction 452 (84.5%)
41 (7.7%)
Other 27 (5.0%)
Injury 15 (2.8%)

Patient Outcomes

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

519 (96.8%)
Required Intervention 8 (1.5%)
Hospitalization 4 (0.7%)
Other 4 (0.7%)
O 1 (0.2%)

Top Product Problems

False Negative Result 96
Low Test Results 39
Smoking 32
High Test Results 29
Electrical /Electronic Property Problem 26
False Positive Result 24
Non Reproducible Results 13
Incorrect, Inadequate or Imprecise Result or Readings 11
Missing Information 6
Use of Device Problem 6
Patient Data Problem 5
Incorrect Or Inadequate Test Results 4
Data Problem 3
Device Markings/Labelling Problem 3
Failure To Run On AC/DC 3
Incorrect Measurement 3
Computer Software Problem 2
Device Difficult to Setup or Prepare 2
Display Difficult to Read 2
No Device Output 2

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: 4

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

Top Manufacturers

ROCHE DIAGNOSTICS 232
SIEMENS HEALTHCARE DIAGNOSTICS INC. 56
SIEMENS HEALTHCARE DIAGNOSTICS INC 10
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 4
ROCHE DIAGNOSTICS CORP. 3

Event Locations

I 254 (47.5%)
180 (33.6%)
OTHER 57 (10.7%)
LABORATORY 22 (4.1%)
HOSPITAL 8 (1.5%)
U 4 (0.7%)
NO INFORMATION 3 (0.6%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Method, Enzymatic, Glucose, 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 (535 here).

Applicator, Absorbent Tipped, Non-Sterile 536 Collector, Ostomy 536 Culture Media 534 Accessories, Pump, Infusion 533

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.