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Hexokinase, Glucose

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Hexokinase, Glucose

The FDA MAUDE database aggregates 37,523 adverse-event reports for Hexokinase, Glucose spanning the period from 1992 through 2026. Of these, 49 are classified as death reports, 5,343 as injury reports, and 31,382 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 15 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 14 distinct product-problem codes appear in the reports, with Low Test Results topping the list at 44 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 11,870 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 13 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

37,523
Total Reports
49
Death Reports
5,343
Injury Reports
31,382
Malfunctions

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

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%)

Top Product Problems

Low Test Results 44
High Test Results 32
Non Reproducible Results 31
Incorrect, Inadequate or Imprecise Result or Readings 10
Incorrect Or Inadequate Test Results 4
Incorrect Measurement 3
Contamination 1
Contamination of Device Ingredient or Reagent 1
False Reading From Device Non-Compliance 1
Low Readings 1
Material Integrity Problem 1
No Apparent Adverse Event 1
Output Problem 1
Unable to Obtain Readings 1

Yearly Trend

92
1992: 15
93
1993: 12
94
1994: 69
95
1995: 24
96
1996: 367
97
1997: 563
98
1998: 398
99
1999: 303
00
2000: 690
01
2001: 2,072
02
2002: 11,870
03
2003: 9,722
04
2004: 5,602
05
2005: 4,559
06
2006: 994
07
2007: 1
08
2008: 2
09
2009: 7
10
2010: 11
11
2011: 43
12
2012: 49
13
2013: 36
14
2014: 2
15
2015: 3
16
2016: 1
17
2017: 13
18
2018: 8
19
2019: 10
20
2020: 4
21
2021: 5
22
2022: 3
23
2023: 29
24
2024: 15
25
2025: 16
26
2026: 5

Related Entities for Hexokinase, Glucose

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%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.