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	69	69
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
Device Operates Differently Than Expected	2	2
Battery Problem	2	2
Failure to Charge	2	2
Smoking	1	1
Appropriate Term/Code Not Available	1	1
Device Dislodged or Dislocated	1	1
Device Displays Incorrect Message	1	1
Charging Problem	1	1
Low Readings	1	1
Device Emits Odor	1	1
Off-Label Use	1	1
Break	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	24	24
No Clinical Signs, Symptoms or Conditions	24	24
No Information	18	18
Chest Pain	12	12
No Code Available	6	6
No Consequences Or Impact To Patient	5	5
Hemorrhage/Bleeding	4	4
Myocardial Infarction	4	4
Atrial Fibrillation	3	3
Pain	3	3
Peripheral Vascular Disease	2	2
Ventricular Tachycardia	2	2
Angina	2	2
Aortic Valve Stenosis	1	1
Nausea	1	1
Hyperglycemia	1	1
High Blood Pressure/ Hypertension	1	1
Laceration(s)	1	1
Exposure to Body Fluids	1	1
Cardiomyopathy	1	1
Cellulitis	1	1
Coagulation Disorder	1	1
Dyspnea	1	1
Cardiac Enzyme Elevation	1	1
Dizziness	1	1
Aneurysm	1	1
Arteriosclerosis/ Atherosclerosis	1	1
Heart Failure/Congestive Heart Failure	1	1
Swelling/ Edema	1	1
Respiratory Distress	1	1
ST Segment Elevation	1	1
Shock	1	1
Transient Ischemic Attack	1	1
Diabetic Ketoacidosis	1	1
Numbness	1	1
Mitral Valve Prolapse	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