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 MAUDE casebook
openFDA event book Assay, Glycosylated Hemoglobin LIGHT-BOOK · MAUDE
#402 of 1000 · 2,919 reports · 2003–2026
- BOOK 2,919 reports
- RANK #402 of 1000
- DEATH 0 death-typed
- INJ 26 injury-typed
- MALF 2,822 malfunction
- SPAN 2003–2026
- PEAK 2018: 1,911
- PHOTO System
Nearest event-volume peer: System, Photopheresis, Extracorporeal (4 report gap)
Assay, Glycosylated Hemoglobin sits #402 of 1000 among tracked device types with 2,919 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 →
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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
- INJ 0.9% corpus 30.4% · below corpus mean (-29.5 pp)
- MALF 96.7% corpus 64.5% · above corpus mean (+32.2 pp)
Lead product-problem code Device Operates Differently Than Expected is 21% of coded problems · Lead manufacturer TOSOH CORPORATION accounts for 87% of manufacturer-tagged reports · Top event location OUTPATIENT DIAGNOSTIC FACILITY is 65% of location-tagged rows .
Assay, Glycosylated Hemoglobin in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Test
Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
2,938 reports
- Dilator
Dilator, Vessel, For Percutaneous Catheterization
2,929 reports
- Assay (this)
Assay, Glycosylated Hemoglobin
2,919 reports
- System
System, Photopheresis, Extracorporeal
2,915 reports
- Adaptor
Adaptor, Hygiene
2,907 reports
- Syringe
Syringe, Antistick
2,905 reports
What this shows Assay, Glycosylated Hemoglobin carries 2,919 MAUDE reports, ranked #402 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
Related Entities for Assay, Glycosylated Hemoglobin
Top Manufacturers
Event Locations
Nationwide devices with similar MAUDE profiles
Two openFDA-derived peer sets for Assay, Glycosylated Hemoglobin, 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 (2,919 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.