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2026 data FDA MAUDE openFDA FDA Class II

System, Multipurpose For In Vitro Coagulation Studies

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 §864.5425 (Hematology panel).

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#250 of 1000 · 7,801 reports · 1996–2026

  • BOOK 7,801 reports
  • RANK #250 of 1000
  • DEATH 39 death-typed
  • INJ 494 injury-typed
  • MALF 7,168 malfunction
  • SPAN 1996–2026
  • PEAK 2007: 1,744
  • PHOTO Defibrillator

Nearest event-volume peer: Defibrillator, Implantable, Dual-Chamber (35 report gap)

System, Multipurpose For In Vitro Coagulation Studies sits #250 of 1000 among tracked device types with 7,801 MAUDE reports spanning 1996–2026. 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 91.9% MALFUNCTION-coded reports, 27.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 6.3% corpus 30.3% · below corpus mean (-24.0 pp)
  • MALF 91.9% corpus 64.8% · above corpus mean (+27.1 pp)

Lead product-problem code High Test Results is 21% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 100% of manufacturer-tagged reports · Top event location is 60% 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, Multipurpose For In Vitro Coagulation Studies carries 7,801 MAUDE reports, ranked #250 of 1000.

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

Event Types

Malfunction 7,168 (91.9%)
Injury 494 (6.3%)
Other 57 (0.7%)
43 (0.6%)
Death 39 (0.5%)

Patient Outcomes

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

6,852 (86.8%)
Other 499 (6.3%)
Required Intervention 198 (2.5%)
Hospitalization 187 (2.4%)
R 68 (0.9%)
Death 38 (0.5%)
Life Threatening 23 (0.3%)
O 9 (0.1%)
H 7 (0.1%)
L 7 (0.1%)
S 5 (0.1%)
Disability 4 (0.1%)
D 1 (0.0%)

Top Product Problems

High Test Results 2,077
Incorrect Or Inadequate Test Results 1,902
Incorrect, Inadequate or Imprecise Result or Readings 1,786
Low Test Results 1,309
Replace 1,284
Measurements, inaccurate 441
Unknown (for use when the device problem is not known) 303
Improper Device Output 207
Device Displays Incorrect Message 67
High Readings 62
Other (for use when an appropriate device code cannot be identified) 44
Use of Device Problem 43
Imprecision 31
Coagulation in Device or Device Ingredient 29
Improper or Incorrect Procedure or Method 29
Component(s), broken 27
Device Operates Differently Than Expected 27
Insufficient Device Problem Information 27
Low Readings 24
Adverse Event Without Identified Device or Use Problem 22

Yearly Trend

96
1996: 1
97
1997: 2
98
1998: 1
00
2000: 11
01
2001: 5
02
2002: 5
03
2003: 28
04
2004: 285
05
2005: 811
06
2006: 1,393
07
2007: 1,744
08
2008: 918
09
2009: 1,363
10
2010: 727
11
2011: 161
12
2012: 52
13
2013: 43
14
2014: 48
15
2015: 45
16
2016: 6
17
2017: 15
18
2018: 39
19
2019: 27
20
2020: 18
21
2021: 7
22
2022: 9
23
2023: 11
24
2024: 8
25
2025: 11
26
2026: 7

Reports in 2025 (11) held close to the prior two-year average of 10.

Related Entities for System, Multipurpose For In Vitro Coagulation Studies

Top Manufacturers

ROCHE DIAGNOSTICS 3,721

Event Locations

4,654 (59.7%)
OTHER 2,081 (26.7%)
NOT APPLICABLE 519 (6.7%)
HOSPITAL 157 (2.0%)
I 116 (1.5%)
AMBULATORY HEALTH CARE FACILITY 83 (1.1%)
UNKNOWN 61 (0.8%)
CLINIC - WALK IN, OTHER 50 (0.6%)
U 45 (0.6%)
HOME 7 (0.1%)
NO INFORMATION 7 (0.1%)
LABORATORY 5 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 5 (0.1%)
INVALID DATA 3 (0.0%)
OUTPATIENT TREATMENT FACILITY 3 (0.0%)
AMBULATORY SURGICAL CENTER 2 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
NURSING HOME 1 (0.0%)

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 (7,801 here).

Defibrillator, Implantable, Dual-Chamber 7,836 Intracranial Neurovascular Stent 7,840 Catheter, Ultrasound, Intravascular 7,853 Catheter 7,737

Similar death-typed counts

Nearest other device types by death-typed report count (39 here), distinct from the volume row.

Airway, Oropharyngeal, Anesthesiology 39 Suture 39 Appliance, Fixation, Spinal Interlaminal 40 Applier, Surgical, Clip 40

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.