TPLC - Total Product Life Cycle

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Device	activated whole blood clotting time
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	81	81
Incorrect Or Inadequate Test Results	12	12
High Test Results	8	8
Overheating of Device	7	7
False Negative Result	5	5
Adverse Event Without Identified Device or Use Problem	3	3
False Positive Result	3	3
Failure to Charge	2	2
Battery Problem	2	2
Device Operates Differently Than Expected	2	2
Smoking	1	1
Charging Problem	1	1
Break	1	1
Off-Label Use	1	1
Low Readings	1	1
Device Emits Odor	1	1
Device Dislodged or Dislocated	1	1
Appropriate Term/Code Not Available	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34	34
No Known Impact Or Consequence To Patient	24	24
No Information	18	18
Chest Pain	13	13
No Code Available	6	6
No Consequences Or Impact To Patient	5	5
Myocardial Infarction	4	4
Hemorrhage/Bleeding	4	4
Atrial Fibrillation	3	3
Pain	3	3
High Blood Pressure/ Hypertension	2	2
Ventricular Tachycardia	2	2
Peripheral Vascular Disease	2	2
Angina	2	2
Respiratory Distress	1	1
Nausea	1	1
Dizziness	1	1
Diabetic Ketoacidosis	1	1
Mitral Valve Prolapse	1	1
Coagulation Disorder	1	1
Cellulitis	1	1
Transient Ischemic Attack	1	1
Chronic Obstructive Pulmonary Disease (COPD)	1	1
Numbness	1	1
Exposure to Body Fluids	1	1
Dyspnea	1	1
Hyperglycemia	1	1
Laceration(s)	1	1
Heart Failure/Congestive Heart Failure	1	1
Cardiomyopathy	1	1
Shock	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Swelling/ Edema	1	1
Aneurysm	1	1
Cardiac Enzyme Elevation	1	1
ST Segment Elevation	1	1
Aortic Valve Stenosis	1	1
Decreased Respiratory Rate	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Point Of Care Inc.	II	Feb-16-2011
2	Abbott Point Of Care Inc.	II	Nov-17-2010
3	Abbott Point of Care Inc.	II	Feb-23-2010
4	International Technidyne Corp.	II	Aug-21-2009