2025 data FDA MAUDE openFDA

Calibrator, Secondary

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 Calibrator, Secondary LIGHT-BOOK · MAUDE

#984 of 1000 · 361 reports · 2000–2025

  • BOOK 361 reports
  • RANK #984 of 1000
  • DEATH 0 death-typed
  • INJ 8 injury-typed
  • MALF 353 malfunction
  • SPAN 2000–2025
  • PEAK 2019: 215
  • PHOTO Applier

Nearest event-volume peer: Applier, Hemostatic Clip (0 report gap)

Calibrator, Secondary sits #984 of 1000 among tracked device types with 361 MAUDE reports spanning 2000–2025. 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 2.2% corpus 30.4% · below corpus mean (-28.2 pp)
  • MALF 97.8% corpus 64.5% · above corpus mean (+33.3 pp)

Lead product-problem code High Test Results is 82% of coded problems · Lead manufacturer ABBOTT LABORATORIES accounts for 69% of manufacturer-tagged reports · Top event location I is 69% of location-tagged rows .

Calibrator, Secondary in the event-volume neighbourhood

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

reports

What this shows Calibrator, Secondary carries 361 MAUDE reports, ranked #984 of 1000.

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

Event Types

Malfunction 353 (97.8%)
Injury 8 (2.2%)

Patient Outcomes

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

351 (97.0%)
Other 6 (1.7%)
Required Intervention 2 (0.6%)
O 1 (0.3%)
Congenital Anomaly 1 (0.3%)
Hospitalization 1 (0.3%)

Top Product Problems

High Test Results 248
Low Test Results 33
Incorrect, Inadequate or Imprecise Result or Readings 9
Adverse Event Without Identified Device or Use Problem 5
Calibration Problem 4
Device Ingredient or Reagent Problem 1
Device Issue 1
Failure to Calibrate 1
High Readings 1
Use of Device Problem 1

Yearly Trend

00
2000: 1
04
2004: 1
05
2005: 4
10
2010: 3
11
2011: 2
12
2012: 10
13
2013: 43
14
2014: 9
15
2015: 6
16
2016: 3
17
2017: 7
18
2018: 8
19
2019: 215
20
2020: 12
21
2021: 3
22
2022: 4
23
2023: 6
24
2024: 17
25
2025: 7

Related Entities for Calibrator, Secondary

Event Locations

I 249 (69.0%)
107 (29.6%)
LABORATORY 3 (0.8%)
NOT APPLICABLE 2 (0.6%)

Compare ABBOTT LABORATORIES vs ORTHO-CLINICAL DIAGNOSTICS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Calibrator, Secondary, 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 (361 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 Calibrator, Secondary 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, Secondary; 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.