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2026 data FDA MAUDE openFDA FDA Class II

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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 Class II (moderate risk, special controls required), regulated under 21 CFR §866.1645 (Microbiology panel).

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#363 of 1000 · 3,810 reports · 2000–2026

  • BOOK 3,810 reports
  • RANK #363 of 1000
  • DEATH 6 death-typed
  • INJ 71 injury-typed
  • MALF 3,731 malfunction
  • SPAN 2000–2026
  • PEAK 2025: 699
  • PHOTO Visual

Nearest event-volume peer: Visual, Pregnancy Hcg, Prescription Use (23 report gap)

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation sits #363 of 1000 among tracked device types with 3,810 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 →

Malfunction reports run above the device-type norm

System carries 97.9% MALFUNCTION-coded reports, 33.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.2% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 1.9% corpus 30.3% · below corpus mean (-28.4 pp)
  • MALF 97.9% corpus 64.8% · above corpus mean (+33.1 pp)

Lead product-problem code Incorrect, Inadequate or Imprecise Result or Readings is 74% of coded problems · Lead manufacturer BECTON DICKINSON & CO. (SPARKS) accounts for 61% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

System in the event-volume neighbourhood

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

reports

What this shows System, Test, Automated, Antimicrobial Susceptibility, Short Incubation carries 3,810 MAUDE reports, ranked #363 of 1000.

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

Event Types

Malfunction 3,731 (97.9%)
Injury 71 (1.9%)
Death 6 (0.2%)
1 (0.0%)
Other 1 (0.0%)

Patient Outcomes

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

3,643 (96.2%)
Required Intervention 73 (1.9%)
Other 27 (0.7%)
Hospitalization 23 (0.6%)
Death 7 (0.2%)
R 4 (0.1%)
Disability 3 (0.1%)
O 2 (0.1%)
Life Threatening 2 (0.1%)
H 1 (0.0%)
L 1 (0.0%)

Top Product Problems

Incorrect, Inadequate or Imprecise Result or Readings 2,811
False Positive Result 228
Incorrect Or Inadequate Test Results 227
Incorrect Measurement 150
Device Contamination with Chemical or Other Material 103
Contamination 41
Device Markings/Labelling Problem 37
False Negative Result 35
Computer Software Problem 22
Mechanical Problem 21
Low Test Results 18
Therapeutic or Diagnostic Output Failure 16
Missing Test Results 13
Contamination of Device Ingredient or Reagent 11
Improper or Incorrect Procedure or Method 11
Use of Device Problem 11
Unable to Obtain Readings 9
Output Problem 7
Adverse Event Without Identified Device or Use Problem 6
Appropriate Device Problem Term/Code Not Available 6

Yearly Trend

00
2000: 1
01
2001: 1
04
2004: 4
05
2005: 7
06
2006: 1
07
2007: 3
08
2008: 1
10
2010: 3
11
2011: 4
12
2012: 9
13
2013: 3
14
2014: 10
15
2015: 41
16
2016: 94
17
2017: 197
18
2018: 512
19
2019: 315
20
2020: 218
21
2021: 232
22
2022: 180
23
2023: 453
24
2024: 418
25
2025: 699
26
2026: 404

Reports rose to 699 in 2025, up from an average of 436 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Top Manufacturers

BECTON DICKINSON & CO. (SPARKS) 1,356
BECTON, DICKINSON & CO. (SPARKS) 858
BECTON, DICKINSON & CO. 7

Event Locations

2,340 (61.4%)
I 1,462 (38.4%)
NOT APPLICABLE 5 (0.1%)
NO INFORMATION 2 (0.1%)
HOSPITAL 1 (0.0%)

Compare BECTON DICKINSON & CO. (SPARKS) vs BECTON, DICKINSON & CO. (SPARKS) →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System: 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 (3,810 here).

Visual, Pregnancy Hcg, Prescription Use 3,833 Covid-19 Multi-Analyte Antigen Device 3,840 Analyzer, Pacemaker Generator Function 3,843 Stapler, Skin 3,772

Similar death-typed counts

Nearest other device types by death-typed report count (6 here), distinct from the volume row.

Applicator, Absorbent Tipped, Non-Sterile 6 Cable, Electrode 6 Catheter, Straight 6 Dilator, Catheter, Ureteral 6

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

Disclaimer: MAUDE figures for System 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 System; 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.