2026 data FDA MAUDE openFDA FDA Class II

Glucose Oxidase, Glucose

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 §862.1345 (Clinical Chemistry panel).

FDA MAUDE casebook

openFDA event book Glucose Oxidase, Glucose LIGHT-BOOK · MAUDE

#256 of 1000 · 7,604 reports · 1997–2026

  • BOOK 7,604 reports
  • RANK #256 of 1000
  • DEATH 14 death-typed
  • INJ 592 injury-typed
  • MALF 6,922 malfunction
  • SPAN 1997–2026
  • PEAK 2023: 1,141
  • PHOTO System

Nearest event-volume peer: System, X-Ray, Angiographic (21 report gap)

Glucose Oxidase, Glucose sits #256 of 1000 among tracked device types with 7,604 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

Glucose Oxidase, Glucose carries 91.0% MALFUNCTION-coded reports, 26.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 7.8% corpus 30.3% · below corpus mean (-22.5 pp)
  • MALF 91.0% corpus 64.8% · above corpus mean (+26.2 pp)

Lead product-problem code Incorrect Or Inadequate Test Results is 13% of coded problems · Lead manufacturer LIFESCAN, INC. accounts for 44% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Glucose Oxidase, Glucose in the event-volume neighbourhood

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

reports

What this shows Glucose Oxidase, Glucose carries 7,604 MAUDE reports, ranked #256 of 1000.

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

Event Types

Malfunction 6,922 (91.0%)
Injury 592 (7.8%)
Other 48 (0.6%)
28 (0.4%)
Death 14 (0.2%)

Patient Outcomes

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

3,844 (49.1%)
Other 3,141 (40.1%)
Hospitalization 319 (4.1%)
R 180 (2.3%)
Required Intervention 173 (2.2%)
Life Threatening 111 (1.4%)
L 32 (0.4%)
Death 16 (0.2%)
O 8 (0.1%)
H 6 (0.1%)
S 2 (0.0%)
Disability 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Incorrect Or Inadequate Test Results 1,188
Incorrect, Inadequate or Imprecise Result or Readings 938
Unable to Obtain Readings 921
High Test Results 786
Replace 783
Computer Software Problem 671
Low Test Results 657
Use of Device Problem 594
Failure, intermittent 476
Wireless Communication Problem 340
High Readings 315
Electrical /Electronic Property Problem 297
Low Readings 282
False Reading From Device Non-Compliance 227
Device Displays Incorrect Message 172
Melted 153
Other (for use when an appropriate device code cannot be identified) 144
Device Expiration Issue 123
Thermal Decomposition of Device 99
Device Operates Differently Than Expected 76

Yearly Trend

97
1997: 8
98
1998: 948
99
1999: 950
00
2000: 910
01
2001: 150
02
2002: 146
03
2003: 84
04
2004: 158
05
2005: 422
06
2006: 211
07
2007: 29
08
2008: 37
09
2009: 75
10
2010: 172
11
2011: 423
12
2012: 233
13
2013: 172
14
2014: 122
15
2015: 155
16
2016: 36
17
2017: 92
18
2018: 69
19
2019: 116
20
2020: 68
21
2021: 48
22
2022: 272
23
2023: 1,141
24
2024: 266
25
2025: 59
26
2026: 32

Reports fell to 59 in 2025, down from an average of 704 in the two years before.

Related Entities for Glucose Oxidase, Glucose

Event Locations

3,634 (47.8%)
NOT APPLICABLE 2,144 (28.2%)
HOME 1,189 (15.6%)
I 409 (5.4%)
OTHER 62 (0.8%)
HOSPITAL 53 (0.7%)
NO INFORMATION 48 (0.6%)
LABORATORY 22 (0.3%)
U 18 (0.2%)
NURSING HOME 15 (0.2%)
AMBULATORY HEALTH CARE FACILITY 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
UNKNOWN 3 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)

Compare LIFESCAN, INC. vs MEDTRONIC MINIMED →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Glucose Oxidase, Glucose: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (7,604 here).

Similar death-typed counts

Nearest other device types by death-typed report count (14 here), distinct from the volume row.

Disclaimer: MAUDE figures for Glucose Oxidase, 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 Glucose Oxidase, 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.