Glucose Dehydrogenase, 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 Dehydrogenase, Glucose MID-BOOK · MAUDE
#53 of 1000 · 74,205 reports · 1998–2026
- BOOK 74,205 reports
- RANK #53 of 1000
- DEATH 33 death-typed
- INJ 5,140 injury-typed
- MALF 68,976 malfunction
- SPAN 1998–2026
- PEAK 2007: 23,819
- PHOTO Transcervical Contrac…
Nearest event-volume peer: Transcervical Contraceptive Tubal Occlusion Device (297 report gap)
Glucose Dehydrogenase, Glucose sits #53 of 1000 among tracked device types with 74,205 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 →
Malfunction reports run above the device-type norm
Glucose Dehydrogenase, Glucose carries 93.0% MALFUNCTION-coded reports, 28.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 6.9% corpus 30.3% · below corpus mean (-23.4 pp)
- MALF 93.0% corpus 64.8% · above corpus mean (+28.1 pp)
Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 28% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 55% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .
Glucose Dehydrogenase, Glucose in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Implant
Implant, Cochlear
75,024 reports
- Transcervical…
Transcervical Contraceptive Tubal Occlusion Device
74,502 reports
- Glucose Dehyd… (this)
Glucose Dehydrogenase, Glucose
74,205 reports
- Gastroscope A…
Gastroscope And Accessories, Flexible/Rigid
73,278 reports
- Set
Set, Administration, For Peritoneal Dialysis, Disposable
72,142 reports
- System
System, Endovascular Graft, Aortic Aneurysm Treatment
71,804 reports
What this shows Glucose Dehydrogenase, Glucose carries 74,205 MAUDE reports, ranked #53 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 836 in 2025, up from an average of 137 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Glucose Dehydrogenase, Glucose
Top Manufacturers
Event Locations
Compare ROCHE DIAGNOSTICS vs ABBOTT DIABETES CARE INC, USA →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Glucose Dehydrogenase, 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 (74,205 here).
Similar death-typed counts
Nearest other device types by death-typed report count (33 here), distinct from the volume row.
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.