Assay, Glycosylated Hemoglobin
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 §864.7470 (Hematology panel).
FDA MAUDE casebook
openFDA event book Assay, Glycosylated Hemoglobin LIGHT-BOOK · MAUDE
#413 of 1000 · 2,943 reports · 2003–2026
- BOOK 2,943 reports
- RANK #413 of 1000
- DEATH 0 death-typed
- INJ 26 injury-typed
- MALF 2,846 malfunction
- SPAN 2003–2026
- PEAK 2018: 1,911
- PHOTO Syringe, Antistick
Nearest event-volume peer: Syringe, Antistick (2 report gap)
Assay, Glycosylated Hemoglobin sits #413 of 1000 among tracked device types with 2,943 MAUDE reports spanning 2003–2026. 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
Assay, Glycosylated Hemoglobin carries 96.7% MALFUNCTION-coded reports, 31.9pp 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 0.9% corpus 30.3% · below corpus mean (-29.4 pp)
- MALF 96.7% corpus 64.8% · above corpus mean (+31.9 pp)
Lead product-problem code Device Operates Differently Than Expected is 17% of coded problems · Lead manufacturer TOSOH CORPORATION accounts for 86% of manufacturer-tagged reports · Top event location OUTPATIENT DIAGNOSTIC FACILITY is 64% of location-tagged rows .
Assay, Glycosylated Hemoglobin in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- System
System, Photopheresis, Extracorporeal
2,966 reports
- Light Source
Light Source, Fiberoptic, Routine
2,959 reports
- Assay (this)
Assay, Glycosylated Hemoglobin
2,943 reports
- Syringe
Syringe, Antistick
2,941 reports
- Spinal Verteb…
Spinal Vertebral Body Replacement Device
2,930 reports
- Aid
Aid, Surgical, Viscoelastic
2,928 reports
What this shows Assay, Glycosylated Hemoglobin carries 2,943 MAUDE reports, ranked #413 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 in 2025 (22) held close to the prior two-year average of 33.
Related Entities for Assay, Glycosylated Hemoglobin
Top Manufacturers
Event Locations
Nationwide devices with a comparable report-volume footprint
Assay, Glycosylated Hemoglobin carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (2,943 here).
Similar death-typed counts
Nearest other device types by death-typed report count (0 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Assay, Glycosylated Hemoglobin 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 Assay, Glycosylated Hemoglobin; 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.