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2026 data FDA MAUDE openFDA

Calibrator, Multi-Analyte Mixture

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.

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FDA MAUDE casebook

openFDA event book Calibrator, Multi-Analyte Mixture LIGHT-BOOK · MAUDE

#825 of 1000 · 573 reports · 2000–2026

  • BOOK 573 reports
  • RANK #825 of 1000
  • DEATH 0 death-typed
  • INJ 8 injury-typed
  • MALF 564 malfunction
  • SPAN 2000–2026
  • PEAK 2008: 173
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Elbow, Semi-Constrained, Cemented (0 report gap)

Calibrator, Multi-Analyte Mixture sits #825 of 1000 among tracked device types with 573 MAUDE reports spanning 2000–2026. 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 1.4% corpus 30.4% · below corpus mean (-29.0 pp)
  • MALF 98.4% corpus 64.5% · above corpus mean (+33.9 pp)

Lead product-problem code High Test Results is 61% of coded problems · Lead manufacturer ABBOTT MANUFACTURING, INC. accounts for 66% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .

Calibrator, Multi-Analyte Mixture in the event-volume neighbourhood

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

reports

What this shows Calibrator, Multi-Analyte Mixture carries 573 MAUDE reports, ranked #825 of 1000.

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

Event Types

Malfunction 564 (98.4%)
Injury 8 (1.4%)
Other 1 (0.2%)

Patient Outcomes

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

556 (97.2%)
Other 6 (1.0%)
Required Intervention 6 (1.0%)
Congenital Anomaly 2 (0.3%)
Death 1 (0.2%)
Hospitalization 1 (0.2%)

Top Product Problems

High Test Results 92
Low Test Results 30
Incorrect, Inadequate or Imprecise Result or Readings 8
Adverse Event Without Identified Device or Use Problem 4
High Readings 4
Incorrect Or Inadequate Test Results 4
Defective Component 2
Non Reproducible Results 2
Chemical Problem 1
Device Sensing Problem 1
False Positive Result 1
Material Split, Cut or Torn 1
No Device Output 1
Unable to Obtain Readings 1

Yearly Trend

00
2000: 1
03
2003: 1
05
2005: 1
07
2007: 140
08
2008: 173
09
2009: 39
11
2011: 9
12
2012: 3
13
2013: 24
14
2014: 35
15
2015: 4
16
2016: 6
17
2017: 17
18
2018: 16
19
2019: 12
20
2020: 22
21
2021: 9
22
2022: 11
23
2023: 13
24
2024: 15
25
2025: 18
26
2026: 4

Related Entities for Calibrator, Multi-Analyte Mixture

Top Manufacturers

ABBOTT MANUFACTURING, INC. 304
ORTHO-CLINICAL DIAGNOSTICS 77
SIEMENS HEALTHCARE DIAGNOSTICS INC. 37
ABBOTT MANUFACTURING, INC 21
ROCHE DIAGNOSTICS 14
BECKMAN COULTER, INC. 6
BECKMAN COULTER INC. 5

Event Locations

476 (83.1%)
I 80 (14.0%)
NO INFORMATION 8 (1.4%)
HOSPITAL 3 (0.5%)
NOT APPLICABLE 2 (0.3%)
OTHER 2 (0.3%)
LABORATORY 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare ABBOTT MANUFACTURING, INC. vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Calibrator, Multi-Analyte Mixture, 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 (573 here).

Prosthesis 573 Pessary, Vaginal 571 Blood/Plasma Collection Device For Dna Test… 576 Culture Media, Non-Propagating Transport 576

Similar death-typed counts

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

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Calibrator, Multi-Analyte Mixture 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 Calibrator, Multi-Analyte Mixture; 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.