2026 data FDA MAUDE openFDA

Blood Grouping Reagent

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 Blood Grouping Reagent LIGHT-BOOK · MAUDE

#929 of 1000 · 451 reports · 2014–2026

  • BOOK 451 reports
  • RANK #929 of 1000
  • DEATH 0 death-typed
  • INJ 3 injury-typed
  • MALF 448 malfunction
  • SPAN 2014–2026
  • PEAK 2021: 90
  • PHOTO Tray, Surgical

Nearest event-volume peer: Tray, Surgical (1 report gap)

Blood Grouping Reagent sits #929 of 1000 among tracked device types with 451 MAUDE reports spanning 2014–2026. 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

Blood Grouping Reagent carries 99.3% MALFUNCTION-coded reports, 34.5pp 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 0.7% corpus 30.3% · below corpus mean (-29.6 pp)
  • MALF 99.3% corpus 64.8% · above corpus mean (+34.5 pp)

Lead product-problem code False Positive Result is 47% of coded problems · Lead manufacturer ORTHO CLINICAL DIAGNOSTICS accounts for 100% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Blood Grouping Reagent in the event-volume neighbourhood

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

reports

What this shows Blood Grouping Reagent carries 451 MAUDE reports, ranked #929 of 1000.

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

Event Types

Malfunction 448 (99.3%)
Injury 3 (0.7%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

441 (98.2%)
Other 4 (0.9%)
Required Intervention 3 (0.7%)
Hospitalization 1 (0.2%)

Top Product Problems

False Positive Result 233
False Negative Result 110
Adverse Event Without Identified Device or Use Problem 52
Incorrect, Inadequate or Imprecise Result or Readings 36
Improper or Incorrect Procedure or Method 14
Output Problem 13
No Apparent Adverse Event 10
Defective Device 8
Defective Component 4
Incorrect Measurement 2
Off-Label Use 2
Patient Device Interaction Problem 2
Appropriate Device Problem Term/Code Not Available 1
Break 1
Device Damaged Prior to Use 1
Display or Visual Feedback Problem 1
Short Fill 1

Yearly Trend

14
2014: 2
17
2017: 1
18
2018: 3
19
2019: 17
20
2020: 84
21
2021: 90
22
2022: 64
23
2023: 82
24
2024: 58
25
2025: 28
26
2026: 22

Reports fell to 28 in 2025, down from an average of 70 in the two years before.

Related Entities for Blood Grouping Reagent

Top Manufacturers

Event Locations

276 (61.2%)
I 175 (38.8%)

Nationwide devices with a comparable report-volume footprint

Blood Grouping Reagent 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 (451 here).

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Disclaimer: MAUDE figures for Blood Grouping Reagent 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 Blood Grouping Reagent; 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.