TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	74	74
Adverse Event Without Identified Device or Use Problem	2	2
Break	1	1
Off-Label Use	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Application Program Problem: Medication Error	1	1
Low Readings	1	1
Appropriate Term/Code Not Available	1	1
Unexpected Therapeutic Results	1	1
Difficult to Open or Close	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	47	47
Chest Pain	7	7
Pain	5	5
Decreased Respiratory Rate	3	3
High Blood Pressure/ Hypertension	2	2
Ischemic Heart Disease	2	2
Atrial Fibrillation	2	2
Heart Failure/Congestive Heart Failure	2	2
Myocardial Infarction	2	2
Hemorrhage/Bleeding	2	2
Stroke/CVA	1	1
Diabetic Ketoacidosis	1	1
Coagulation Disorder	1	1
Hematoma	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
Unspecified Eye / Vision Problem	1	1
Hyperglycemia	1	1
Laceration(s)	1	1
Cardiomyopathy	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Swelling/ Edema	1	1
Cardiac Enzyme Elevation	1	1
Pulmonary Embolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Accriva Diagnostics, Inc.	II	Dec-03-2025
2	Medtronic Perfusion Systems	II	Nov-18-2025