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TPLC
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show TPLC since
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Device
activated whole blood clotting time
Product Code
JBP
Regulation Number
864.7140
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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