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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
2014 3 3
2015 26 26
2016 4 4
2017 16 16
2018 1 1
2019 15 15
2020 10 10
2021 9 9
2022 7 7
2023 17 17
2024 18 18

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
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