TPLC - Total Product Life Cycle

• Device: activated whole blood clotting time
• Regulation Description: Activated whole blood clotting time tests.
• Product Code: JBP
• Regulation Number: 864.7140
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
SIENCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
1.  K223635  Sonoclot Coagulation & Platelet Function Analyzer ...

MDR Year	MDR Reports	MDR Events
2020	10	10
2021	9	9
2022	7	7
2023	17	17
2024	23	23
2025	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	64	64
Adverse Event Without Identified Device or Use Problem	2	2
Off-Label Use	1	1
Appropriate Term/Code Not Available	1	1
Break	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	39	39
Chest Pain	10	10
Myocardial Infarction	4	4
Pain	3	3
No Information	2	2
Decreased Respiratory Rate	2	2
High Blood Pressure/ Hypertension	2	2
Dyspnea	1	1
Exposure to Body Fluids	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Heart Failure/Congestive Heart Failure	1	1
ST Segment Elevation	1	1
Laceration(s)	1	1
Cellulitis	1	1
Aortic Valve Stenosis	1	1
Cardiomyopathy	1	1
Diabetic Ketoacidosis	1	1
Hemorrhage/Bleeding	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Transient Ischemic Attack	1	1
Coagulation Disorder	1	1
Hyperglycemia	1	1
Angina	1	1
Ventricular Tachycardia	1	1
Dizziness	1	1
Swelling/ Edema	1	1
Respiratory Distress	1	1
Ischemic Heart Disease	1	1
No Code Available	1	1
Cardiac Enzyme Elevation	1	1
Nausea	1	1