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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device activated whole blood clotting time
Product CodeJBP
Regulation Number 864.7140
Device Class 2


Premarket Reviews
ManufacturerDecision
SIENCO, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 10 10
2021 9 9
2022 7 7
2023 17 17
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 62 62
Adverse Event Without Identified Device or Use Problem 2 2
Break 1 1
Off-Label Use 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37 37
Chest Pain 10 10
Myocardial Infarction 4 4
Pain 3 3
High Blood Pressure/ Hypertension 2 2
No Information 2 2
Decreased Respiratory Rate 2 2
Nausea 1 1
Respiratory Distress 1 1
No Code Available 1 1
Ventricular Tachycardia 1 1
Dizziness 1 1
Diabetic Ketoacidosis 1 1
Coagulation Disorder 1 1
Ischemic Heart Disease 1 1
Cellulitis 1 1
Transient Ischemic Attack 1 1
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Angina 1 1
Exposure to Body Fluids 1 1
Dyspnea 1 1
Hyperglycemia 1 1
Laceration(s) 1 1
Cardiomyopathy 1 1
Heart Failure/Congestive Heart Failure 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Swelling/ Edema 1 1
Cardiac Enzyme Elevation 1 1
Hemorrhage/Bleeding 1 1
Aortic Valve Stenosis 1 1
ST Segment Elevation 1 1

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