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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, time, prothrombin
Product CodeGJS
Regulation Number 864.7750
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
COAGUSENSE, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTICA STAGO SAS
  SUBSTANTIALLY EQUIVALENT 1
ILINE MICROSYSTEMS S.L.
  SUBSTANTIALLY EQUIVALENT 3
INSTRUMENTATION LABORATORY CO.
  SUBSTANTIALLY EQUIVALENT 1
UNIVERSAL BIOSENSORS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2385 2385
2020 1390 1390
2021 1359 1359
2022 1210 1210
2023 809 809
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 4509 4509
Incorrect, Inadequate or Imprecise Result or Readings 842 842
Non Reproducible Results 645 645
Low Test Results 563 563
Image Display Error/Artifact 342 342
Display Difficult to Read 178 178
Circuit Failure 91 91
Incorrect Measurement 74 74
Adverse Event Without Identified Device or Use Problem 43 43
Device Difficult to Setup or Prepare 41 41
No Device Output 34 34
High Readings 22 22
Display or Visual Feedback Problem 18 18
Lack of Maintenance Documentation or Guidelines 16 16
Improper or Incorrect Procedure or Method 9 9
Device Handling Problem 8 8
Nonstandard Device 8 8
Low Readings 7 7
Output Problem 7 7
Off-Label Use 6 6
Failure to Power Up 5 5
Unexpected Therapeutic Results 4 4
Erratic or Intermittent Display 4 4
Insufficient Information 4 4
Misassembly by Users 3 3
Inaccurate Information 3 3
Patient Data Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Human-Device Interface Problem 3 3
Use of Device Problem 3 3
Battery Problem 3 3
Calibration Problem 3 3
Loss of Data 3 3
Device Markings/Labelling Problem 3 3
Device Sensing Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Audible Prompt/Feedback Problem 2 2
No Display/Image 2 2
Computer Software Problem 2 2
Contamination 2 2
Mechanical Problem 2 2
Melted 2 2
Smoking 2 2
Date/Time-Related Software Problem 2 2
Device Displays Incorrect Message 2 2
Unable to Obtain Readings 2 2
Failure to Transmit Record 2 2
Overheating of Device 1 1
Shipping Damage or Problem 1 1
Application Program Problem 1 1
Inadequate or Insufficient Training 1 1
Poor Quality Image 1 1
Thermal Decomposition of Device 1 1
Labelling, Instructions for Use or Training Problem 1 1
Crack 1 1
Material Discolored 1 1
Electrical /Electronic Property Problem 1 1
Activation Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Data Problem 1 1
Unclear Information 1 1
Defective Component 1 1
Tear, Rip or Hole in Device Packaging 1 1
Fail-Safe Problem 1 1
Compatibility Problem 1 1
Material Twisted/Bent 1 1
Power Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 3799 3799
No Clinical Signs, Symptoms or Conditions 3042 3042
Insufficient Information 77 77
No Known Impact Or Consequence To Patient 68 68
No Information 51 51
Coagulation Disorder 32 32
Stroke/CVA 23 23
Thrombosis/Thrombus 20 20
Ischemia Stroke 17 17
Transient Ischemic Attack 15 15
Thromboembolism 12 12
Hemorrhage/Bleeding 11 11
Atrial Fibrillation 9 9
Hemorrhagic Stroke 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Gastrointestinal Hemorrhage 7 7
Pulmonary Embolism 7 7
Speech Disorder 6 6
Dizziness 6 6
No Patient Involvement 5 5
Pain 5 5
Thrombosis 4 4
Chest Pain 4 4
Numbness 4 4
Balance Problems 3 3
Confusion/ Disorientation 3 3
Hematuria 3 3
Thrombus 3 3
Myocardial Infarction 3 3
High Blood Pressure/ Hypertension 3 3
Ischemia 3 3
Laceration(s) 2 2
Fall 2 2
Cardiac Enzyme Elevation 2 2
Angina 2 2
Apnea 2 2
Patient Problem/Medical Problem 2 2
Test Result 2 2
Valvular Stenosis 2 2
Respiratory Failure 2 2
Cognitive Changes 2 2
Urinary Tract Infection 2 2
Blurred Vision 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Vomiting 1 1
Misdiagnosis 1 1
Chills 1 1
Neck Pain 1 1
Quadriplegia 1 1
Wound Dehiscence 1 1
Anxiety 1 1
Reaction 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Movement Disorder 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Epistaxis 1 1
Pulmonary Hypertension 1 1
Arrhythmia 1 1
Atherosclerosis 1 1
Abdominal Pain 1 1
Anemia 1 1
Biliary Cirrhosis 1 1
Bruise/Contusion 1 1
Fainting 1 1
Death 1 1
Dyspnea 1 1
Embolism 1 1
Headache 1 1
Intracranial Hemorrhage 1 1
Hepatitis 1 1
Muscle Spasm(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Oversedation 1 1
Paresis 1 1
Phlebitis 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Sepsis 1 1
Melena 1 1
Unspecified Kidney or Urinary Problem 1 1
Easy Bruising 1 1
Unspecified Nervous System Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Instrumentation Laboratory II May-10-2022
2 Instrumentation Laboratory II Nov-23-2021
3 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
4 Roche Diagnostics Operations, Inc. II Jan-07-2021
5 TERRIFIC CARE LLC I Feb-01-2019
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