What are FDA adverse event reports for Hexokinase, Glucose?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Hexokinase, Glucose, there are 37,523 total reports including 49 death reports and 5,343 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 Hexokinase, 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

Hexokinase, Glucose

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

#90 of 1000 · 37,523 reports · 1992–2026

BOOK 37,523 reports
RANK #90 of 1000
DEATH 49 death-typed
INJ 5,343 injury-typed
MALF 31,382 malfunction
SPAN 1992–2026
PEAK 2002: 11,870
PHOTO Device

Nearest event-volume peer: Device, Impotence, Mechanical/Hydraulic (310 report gap)

Hexokinase, Glucose sits #90 of 1000 among tracked device types with 37,523 MAUDE reports spanning 1992–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
INJ 14.2% corpus 30.4% · below corpus mean (-16.2 pp)
MALF 83.6% corpus 64.5% · above corpus mean (+19.1 pp)

Lead product-problem code Low Test Results is 33% of coded problems · Lead manufacturer LIFESCAN, INC. accounts for 87% of manufacturer-tagged reports · Top event location NOT APPLICABLE is 87% of location-tagged rows .

Introducer

38,107
Temporary Non…

38,070
Plate

37,887
Insulin Pump…

37,844
Hexokinase (this)

37,523
Device

37,213

What this shows Hexokinase, Glucose carries 37,523 MAUDE reports, ranked #90 of 1000.

Event Types

Malfunction 31,382 (83.6%)

Injury 5,343 (14.2%)

499 (1.3%)

Other 250 (0.7%)

Death 49 (0.1%)

Patient Outcomes

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

29,727 (73.5%)

Hospitalization 2,818 (7.0%)

R 1,954 (4.8%)

Other 1,937 (4.8%)

Required Intervention 1,514 (3.7%)

Life Threatening 970 (2.4%)

L 919 (2.3%)

Disability 502 (1.2%)

Death 61 (0.2%)

O 18 (0.0%)

S 11 (0.0%)

H 4 (0.0%)

Congenital Anomaly 2 (0.0%)

I 1 (0.0%)

Invalid Data 1 (0.0%)

Yearly Trend

1992: 15

1993: 12

1994: 69

1995: 24

1996: 367

1997: 563

1998: 398

1999: 303

2000: 690

2001: 2,072

2002: 11,870

2003: 9,722

2004: 5,602

2005: 4,559

2006: 994

2007: 1

2008: 2

2009: 7

2010: 11

2011: 43

2012: 49

2013: 36

2014: 2

2015: 3

2016: 1

2017: 13

2018: 8

2019: 10

2020: 4

2021: 5

2022: 3

2023: 29

2024: 15

2025: 16

2026: 5

Top Manufacturers

LIFESCAN, INC. 29,419

ROCHE DIAGNOSTICS 3,354

ROCHE DIAGNOSTICS CORP. 858

BAYER HEALTHCARE, LLC 129

Event Locations

NOT APPLICABLE 32,602 (86.9%)

3,541 (9.4%)

INVALID DATA 575 (1.5%)

HOME 292 (0.8%)

OTHER 197 (0.5%)

HOSPITAL 100 (0.3%)

UNKNOWN 80 (0.2%)

LABORATORY 47 (0.1%)

I 45 (0.1%)

OUTPATIENT TREATMENT FACILITY 18 (0.0%)

NO INFORMATION 15 (0.0%)

NURSING HOME 9 (0.0%)

OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)

Compare LIFESCAN, INC. vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Hexokinase, 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 (37,523 here).

Device, Impotence, Mechanical/Hydraulic 37,213 Insulin Pump Secondary Display 37,844 Plate, Fixation, Bone 37,887 Temporary Non-Roller Type Left Heart Suppor… 38,070

Similar death-typed counts

Nearest other device types by death-typed report count (49 here), distinct from the volume row.

Needle, Fistula 49 Prosthesis 49 Pulmonic Valved Conduit 48 Unit, Cryosurgical, Accessories 50

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

Disclaimer: MAUDE figures for Hexokinase, 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 Hexokinase, 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.

Hexokinase, Glucose

Event-type mix vs corpus