2026 data FDA MAUDE openFDA FDA Class II

Hexokinase, 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 Hexokinase, Glucose MID-BOOK · MAUDE

#92 of 1000 · 37,534 reports · 1992–2026

  • BOOK 37,534 reports
  • RANK #92 of 1000
  • DEATH 49 death-typed
  • INJ 5,343 injury-typed
  • MALF 31,393 malfunction
  • SPAN 1992–2026
  • PEAK 2002: 11,870
  • PHOTO Rod

Nearest event-volume peer: Rod, Fixation, Intramedullary And Accessories (63 report gap)

Hexokinase, Glucose sits #92 of 1000 among tracked device types with 37,534 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 →

Malfunction reports run above the device-type norm

Hexokinase, Glucose carries 83.6% MALFUNCTION-coded reports, 18.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 14.2% corpus 30.3% · below corpus mean (-16.1 pp)
  • MALF 83.6% corpus 64.8% · above corpus mean (+18.8 pp)

Lead product-problem code Incorrect Or Inadequate Test Results is 41% of coded problems · Lead manufacturer LIFESCAN, INC. accounts for 89% of manufacturer-tagged reports · Top event location NOT APPLICABLE is 87% of location-tagged rows .

Hexokinase, Glucose in the event-volume neighbourhood

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

reports

What this shows Hexokinase, Glucose carries 37,534 MAUDE reports, ranked #92 of 1000.

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

Event Types

Malfunction 31,393 (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.

29,737 (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

Incorrect Or Inadequate Test Results 21,296
Replace 8,574
High Test Results 6,748
Low Test Results 2,619
High Readings 2,008
Device Displays Incorrect Message 1,837
Use of Device Problem 1,386
Failure to Power Up 1,265
Low Readings 961
Unable to Obtain Readings 956
No Display/Image 639
Device Expiration Issue 548
Erratic or Intermittent Display 487
Device Issue 481
Loss of Power 396
Incorrect, Inadequate or Imprecise Result or Readings 393
Component Missing 348
Other (for use when an appropriate device code cannot be identified) 332
Repair 299
Calibration Error 261

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: 16

Reports in 2025 (16) held close to the prior two-year average of 22.

Related Entities for Hexokinase, Glucose

Top Manufacturers

Event Locations

NOT APPLICABLE 32,602 (86.9%)
3,552 (9.5%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Hexokinase, 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 (37,534 here).

Similar death-typed counts

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

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.