2026 data FDA MAUDE openFDA

Enzyme Linked Immunoabsorbent Assay, Rubella

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 Enzyme Linked Immunoabsorbent Assay, Rubella LIGHT-BOOK · MAUDE

#741 of 1000 · 756 reports · 2007–2026

  • BOOK 756 reports
  • RANK #741 of 1000
  • DEATH 0 death-typed
  • INJ 3 injury-typed
  • MALF 748 malfunction
  • SPAN 2007–2026
  • PEAK 2008: 367
  • PHOTO Mesh

Nearest event-volume peer: Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator (0 report gap)

Enzyme Linked Immunoabsorbent Assay, Rubella sits #741 of 1000 among tracked device types with 756 MAUDE reports spanning 2007–2026. 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 0.4% corpus 30.4% · below corpus mean (-30.0 pp)
  • MALF 98.9% corpus 64.5% · above corpus mean (+34.4 pp)

Lead product-problem code High Test Results is 21% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 58% of manufacturer-tagged reports · Top event location is 77% of location-tagged rows .

Enzyme Linked Immunoabsorbent Assay, Rubella in the event-volume neighbourhood

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

reports

What this shows Enzyme Linked Immunoabsorbent Assay, Rubella carries 756 MAUDE reports, ranked #741 of 1000.

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

Event Types

Malfunction 748 (98.9%)
Other 4 (0.5%)
Injury 3 (0.4%)
1 (0.1%)

Patient Outcomes

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

746 (98.8%)
Required Intervention 7 (0.9%)
Other 2 (0.3%)

Top Product Problems

High Test Results 40
Device Ingredient or Reagent Problem 33
False Positive Result 26
Low Test Results 20
False Negative Result 19
Incorrect, Inadequate or Imprecise Result or Readings 14
Adverse Event Without Identified Device or Use Problem 11
No Apparent Adverse Event 11
Incorrect Or Inadequate Test Results 6
Non Reproducible Results 5
Incorrect Measurement 1
Insufficient Information 1
Low Readings 1
Use of Device Problem 1

Yearly Trend

07
2007: 5
08
2008: 367
09
2009: 19
10
2010: 18
11
2011: 89
12
2012: 37
13
2013: 15
14
2014: 13
15
2015: 15
16
2016: 47
17
2017: 10
18
2018: 24
19
2019: 16
20
2020: 21
21
2021: 13
22
2022: 13
23
2023: 7
24
2024: 13
25
2025: 12
26
2026: 2

Related Entities for Enzyme Linked Immunoabsorbent Assay, Rubella

Event Locations

585 (77.4%)
I 129 (17.1%)
LABORATORY 30 (4.0%)
OTHER 12 (1.6%)

Compare ABBOTT LABORATORIES vs ROCHE DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Enzyme Linked Immunoabsorbent Assay, Rubella, 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 (756 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 Enzyme Linked Immunoabsorbent Assay, Rubella 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 Enzyme Linked Immunoabsorbent Assay, Rubella; 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.