Reagent Red Blood Cells
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 Reagent Red Blood Cells LIGHT-BOOK · MAUDE
#980 of 1000 · 389 reports · 2018–2026
- BOOK 389 reports
- RANK #980 of 1000
- DEATH 2 death-typed
- INJ 2 injury-typed
- MALF 385 malfunction
- SPAN 2018–2026
- PEAK 2020: 89
- PHOTO Accessories
Nearest event-volume peer: Accessories, Catheter, G-U (3 report gap)
Reagent Red Blood Cells sits #980 of 1000 among tracked device types with 389 MAUDE reports spanning 2018–2026. 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
Reagent Red Blood Cells carries 99.0% MALFUNCTION-coded reports, 34.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
- INJ 0.5% corpus 30.3% · below corpus mean (-29.8 pp)
- MALF 99.0% corpus 64.8% · above corpus mean (+34.1 pp)
Lead product-problem code False Negative Result is 70% of coded problems · Lead manufacturer ORTHO CLINICAL DIAGNOSTICS accounts for 100% of manufacturer-tagged reports · Top event location is 62% of location-tagged rows .
Reagent Red Blood Cells in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Accessories
Accessories, Catheter, G-U
392 reports
- Controller
Controller, Foot, Handpiece And Cord
392 reports
- Reagent Red B… (this)
Reagent Red Blood Cells
389 reports
- Blood Pump Fo…
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
386 reports
- Catheter
Catheter, Cholangiography
386 reports
- Indicator
Indicator, Physical/Chemical Sterilization Process
386 reports
What this shows Reagent Red Blood Cells carries 389 MAUDE reports, ranked #980 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 (51) held close to the prior two-year average of 50.
Related Entities for Reagent Red Blood Cells
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Reagent Red Blood Cells: 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 (389 here).
Similar death-typed counts
Nearest other device types by death-typed report count (2 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Reagent Red Blood Cells 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 Reagent Red Blood Cells; 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.