What are FDA adverse event reports for Glucose Dehydrogenase, Glucose?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Glucose Dehydrogenase, Glucose, there are 73,910 total reports including 33 death reports and 5,130 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 Glucose Dehydrogenase, Glucose?

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

Glucose Dehydrogenase, Glucose

Name: Glucose Dehydrogenase, Glucose - 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 Glucose Dehydrogenase, Glucose MID-BOOK · MAUDE

#49 of 1000 · 73,910 reports · 1998–2026

BOOK 73,910 reports
RANK #49 of 1000
DEATH 33 death-typed
INJ 5,130 injury-typed
MALF 68,691 malfunction
SPAN 1998–2026
PEAK 2007: 23,813
PHOTO Transcervical Contrac…

Nearest event-volume peer: Transcervical Contraceptive Tubal Occlusion Device (448 report gap)

Glucose Dehydrogenase, Glucose sits #49 of 1000 among tracked device types with 73,910 MAUDE reports spanning 1998–2026. 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 6.9% corpus 30.4% · below corpus mean (-23.5 pp)
MALF 92.9% corpus 64.5% · above corpus mean (+28.4 pp)

Lead product-problem code Incorrect Or Inadequate Test Results is 42% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 55% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Transcervical…

74,358
Glucose Dehyd… (this)

73,910
Implant

72,793
Aortic Valve

72,550
Cabinet

71,750
Set

71,401

What this shows Glucose Dehydrogenase, Glucose carries 73,910 MAUDE reports, ranked #49 of 1000.

Event Types

Malfunction 68,691 (92.9%)

Injury 5,130 (6.9%)

Death 33 (0.0%)

Other 32 (0.0%)

24 (0.0%)

Patient Outcomes

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

68,567 (90.8%)

Required Intervention 2,763 (3.7%)

Hospitalization 1,639 (2.2%)

R 1,407 (1.9%)

Other 620 (0.8%)

Life Threatening 265 (0.4%)

L 164 (0.2%)

O 38 (0.1%)

Death 38 (0.1%)

H 27 (0.0%)

Congenital Anomaly 12 (0.0%)

Disability 10 (0.0%)

S 3 (0.0%)

D 1 (0.0%)

Yearly Trend

1998: 8

1999: 13

2000: 20

2001: 119

2002: 260

2003: 296

2004: 835

2005: 1,118

2006: 2,767

2007: 23,813

2008: 6,583

2009: 10,822

2010: 4,865

2011: 3,802

2012: 3,341

2013: 3,821

2014: 3,960

2015: 3,366

2016: 2,145

2017: 103

2018: 108

2019: 108

2020: 132

2021: 164

2022: 101

2023: 103

2024: 171

2025: 836

2026: 130

Top Manufacturers

ROCHE DIAGNOSTICS 38,417

ABBOTT DIABETES CARE INC, USA 16,183

ROCHE DIABETES CARE, INC. 4,709

ABBOTT DIABETES CARE INC. 4,475

ABBOTT DIABETES CARE INC., USA 4,404

ROCHE DIAGNOSTICS CORP. 1,133

ABBOTT DIABETES CARE INC. USA 639

ABBOTT DIABETES CARE INC 406

Event Locations

31,800 (43.0%)

OTHER 14,470 (19.6%)

U 12,107 (16.4%)

HOME 6,689 (9.1%)

HOSPITAL 2,832 (3.8%)

I 2,506 (3.4%)

UNKNOWN 1,907 (2.6%)

NOT APPLICABLE 1,040 (1.4%)

NO INFORMATION 104 (0.1%)

SCHOOL 87 (0.1%)

AMBULATORY HEALTH CARE FACILITY 80 (0.1%)

PATIENT'S HOME 72 (0.1%)

CLINIC - WALK IN, OTHER 48 (0.1%)

NURSING HOME 42 (0.1%)

LABORATORY 38 (0.1%)

LONG-TERM CARE FACILITY 21 (0.0%)

REHABILITATION CENTER 15 (0.0%)

EMERGENCY ROOM 9 (0.0%)

OUTPATIENT TREATMENT FACILITY 5 (0.0%)

RETIREMENT HOME 5 (0.0%)

OUTDOORS 4 (0.0%)

PSYCHIATRIC FACILITY 4 (0.0%)

PUBLIC BUILDING 4 (0.0%)

AMBULATORY SURGICAL CENTER 3 (0.0%)

CRITICAL CARE UNIT 3 (0.0%)

AMBULATORY SURGICAL FACILITY 2 (0.0%)

EXAMINATION ROOM 2 (0.0%)

INVALID DATA 2 (0.0%)

PARK 2 (0.0%)

STREET 2 (0.0%)

DIALYSIS CENTER 1 (0.0%)

DIALYSIS UNIT 1 (0.0%)

IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)

PUBLIC VENUE 1 (0.0%)

URGENT CARE CENTER 1 (0.0%)

Compare ROCHE DIAGNOSTICS vs ABBOTT DIABETES CARE INC, USA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Glucose Dehydrogenase, 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 (73,910 here).

Transcervical Contraceptive Tubal Occlusion… 74,358 Implant, Cochlear 72,793 Aortic Valve 72,550 Cabinet, Table And Tray, Anesthesia 71,750

Similar death-typed counts

Nearest other device types by death-typed report count (33 here), distinct from the volume row.

Bed, Air Fluidized 33 Catheter, Umbilical Artery 33 Electrocardiograph 33 Percutaneously Delivered Prostheses And Tri… 33

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

Disclaimer: MAUDE figures for Glucose Dehydrogenase, 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 Dehydrogenase, 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.

Glucose Dehydrogenase, Glucose

Event-type mix vs corpus