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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, multipurpose for in vitro coagulation studies
Product CodeJPA
Regulation Number 864.5425
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCRIVA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORAMED TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC GRIFOLS, S.A.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO SAS
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
HAEMONETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 3
PENTAPHARM GMBH
  SUBSTANTIALLY EQUIVALENT 1
SEKISUI MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTIC PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
  SUBSTANTIALLY EQUIVALENT 6
TEM INNOVATIONS GMBH
  SUBSTANTIALLY EQUIVALENT 2
TRINITY BIOTECH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 48 48
2015 45 45
2016 6 6
2017 15 15
2018 39 39
2019 27 27
2020 18 18
2021 7 7
2022 9 9
2023 11 11
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 56 56
Low Test Results 35 35
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Adverse Event Without Identified Device or Use Problem 19 19
Incorrect Or Inadequate Test Results 19 19
Use of Device Problem 15 15
Insufficient Information 13 13
Improper or Incorrect Procedure or Method 7 7
Overheating of Device 7 7
Thermal Decomposition of Device 6 6
Incorrect Measurement 5 5
Appropriate Term/Code Not Available 5 5
Output Problem 4 4
Leak/Splash 3 3
Computer Software Problem 3 3
False Negative Result 3 3
Use of Incorrect Control/Treatment Settings 2 2
Device Maintenance Issue 2 2
Inadequate Instructions for Healthcare Professional 2 2
Smoking 2 2
Inadequate or Insufficient Training 2 2
Material Twisted/Bent 2 2
Device Operates Differently Than Expected 2 2
Electrical Shorting 2 2
Data Problem 2 2
Device Handling Problem 2 2
Noise, Audible 1 1
Non Reproducible Results 1 1
Misassembly During Maintenance/Repair 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Output below Specifications 1 1
Installation-Related Problem 1 1
Maintenance Does Not Comply To Manufacturers Recommendations 1 1
Mechanics Altered 1 1
Off-Label Use 1 1
High Readings 1 1
Low Readings 1 1
Failure to Obtain Sample 1 1
Device Displays Incorrect Message 1 1
Break 1 1
Melted 1 1
Misconnection 1 1
Occlusion Within Device 1 1
Device Emits Odor 1 1
No Device Output 1 1
Erratic or Intermittent Display 1 1
Charred 1 1
Device Reprocessing Problem 1 1
False Positive Result 1 1
False Reading From Device Non-Compliance 1 1
Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 137 137
No Clinical Signs, Symptoms or Conditions 24 24
No Consequences Or Impact To Patient 22 22
Hematoma 5 5
Hemorrhage/Bleeding 5 5
Death 5 5
Thrombosis 4 4
Insufficient Information 4 4
Missing Value Reason 4 4
No Patient Involvement 4 4
Patient Problem/Medical Problem 3 3
Needle Stick/Puncture 3 3
Chemical Exposure 3 3
Blood Loss 3 3
Pulmonary Embolism 3 3
Exposure to Body Fluids 3 3
Aortic Dissection 2 2
Misdiagnosis 2 2
No Code Available 2 2
Thrombosis/Thrombus 1 1
Not Applicable 1 1
No Information 1 1
Thromboembolism 1 1
Confusion/ Disorientation 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Coagulation Disorder 1 1
Abrasion 1 1
Embolus 1 1
Ventricular Fibrillation 1 1
Injury 1 1
Loss of consciousness 1 1
Hemorrhage, Subarachnoid 1 1
Miscarriage 1 1
Myocardial Infarction 1 1
Pleural Effusion 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accriva Diagnostics Inc., dba ITC, dba Accumetrics II May-25-2016
2 Diagnostica Stago, Inc. II May-10-2023
3 Diagnostica Stago, Inc. II Nov-06-2012
4 Haemonetics Corporation II Jun-30-2022
5 Haemonetics Corporation II Jun-28-2022
6 Haemonetics Corporation II Mar-31-2020
7 Haemonetics Corporation II Feb-19-2015
8 Haemonetics Corporation II Jul-24-2013
9 Haemoscope Division of Haemonetics Corp II Jul-06-2011
10 Haemoscope Division of Haemonetics Corp II Mar-21-2011
11 Helena Laboratories, Corp. II Dec-17-2020
12 ITC-Nexus Dx II Jul-21-2014
13 Instrumentation Laboratory Co. II Sep-06-2019
14 Instrumentation Laboratory Co. II Dec-27-2010
15 International Technidyne Corp. II Aug-05-2011
16 Medtronic Inc. Cardiac Rhythm Disease Managment II May-04-2010
17 Siemens Healthcare Diagnostics, Inc. II Apr-19-2021
18 Siemens Healthcare Diagnostics, Inc. II Feb-19-2016
19 Siemens Healthcare Diagnostics, Inc. II Jun-26-2012
20 TEM Systems Inc II Oct-23-2016
21 TEM Systems Inc II Apr-03-2015
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