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2025 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book System LIGHT-BOOK · MAUDE

#241 of 1000 · 7,794 reports · 1996–2025

  • BOOK 7,794 reports
  • RANK #241 of 1000
  • DEATH 38 death-typed
  • INJ 494 injury-typed
  • MALF 7,162 malfunction
  • SPAN 1996–2025
  • PEAK 2007: 1,744
  • PHOTO Dermatome

Nearest event-volume peer: Dermatome (12 report gap)

System, Multipurpose For In Vitro Coagulation Studies sits #241 of 1000 among tracked device types with 7,794 MAUDE reports spanning 1996–2025. 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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 6.3% corpus 30.4% · below corpus mean (-24.1 pp)
  • MALF 91.9% corpus 64.5% · above corpus mean (+27.4 pp)

Lead product-problem code Low Test Results is 14% of coded problems · Lead manufacturer ROCHE DIAGNOSTICS accounts for 92% 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 7,794 MAUDE reports, ranked #241 of 1000.

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

Event Types

Malfunction 7,162 (91.9%)
Injury 494 (6.3%)
Other 57 (0.7%)
43 (0.6%)
Death 38 (0.5%)

Patient Outcomes

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

6,852 (86.8%)
Other 496 (6.3%)
Required Intervention 198 (2.5%)
Hospitalization 187 (2.4%)
R 68 (0.9%)
Death 37 (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

Low Test Results 23
Incorrect, Inadequate or Imprecise Result or Readings 20
High Test Results 18
Use of Device Problem 17
Insufficient Information 15
Adverse Event Without Identified Device or Use Problem 12
Incorrect Or Inadequate Test Results 8
False Negative Result 7
Overheating of Device 7
Thermal Decomposition of Device 6
Improper or Incorrect Procedure or Method 5
Appropriate Term/Code Not Available 4
Incorrect Measurement 4
Output Problem 4
Computer Software Problem 3
Data Problem 3
Leak/Splash 3
Electrical Shorting 2
Material Twisted/Bent 2
Smoking 2

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

Related Entities for System, Multipurpose For In Vitro Coagulation Studies

Top Manufacturers

ROCHE DIAGNOSTICS 3,721
ROCHE DIAGNOSTICS CORP. 314

Event Locations

4,648 (59.6%)
OTHER 2,081 (26.7%)
NOT APPLICABLE 519 (6.7%)
HOSPITAL 156 (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%)

Compare ROCHE DIAGNOSTICS vs ROCHE DIAGNOSTICS CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, 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 (7,794 here).

Dermatome 7,806 Device, Microtiter Diluting/Dispensing 7,707 Defibrillator, Implantable, Dual-Chamber 7,651 Accessories, Soft Lens Products 7,993

Similar death-typed counts

Nearest other device types by death-typed report count (38 here), distinct from the volume row.

Temporary Coronary Saphenous Vein Bypass Gr… 38 Airway, Oropharyngeal, Anesthesiology 39 Stimulator 39 Suture 39

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.