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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
Regulation Description Activated whole blood clotting time tests.
Product CodeJBP
Regulation Number 864.7140
Device Class 2

MDR Year MDR Reports MDR Events
2016 4 4
2017 16 16
2018 1 1
2019 15 15
2020 10 10
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 36 36
False Negative Result 5 5
False Positive Result 3 3
Incorrect Or Inadequate Test Results 2 2
Device Operates Differently Than Expected 1 1
Device Dislodged or Dislocated 1 1
Device Emits Odor 1 1
Smoking 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 17 17
Chest Pain 8 8
No Code Available 5 5
Atrial Fibrillation 3 3
Angina 2 2
Peripheral Vascular Disease 2 2
Myocardial Infarction 2 2
Ventricular Tachycardia 2 2
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Numbness 1 1
Aneurysm 1 1
Aortic Valve Stenosis 1 1
Dyspnea 1 1
ST Segment Elevation 1 1
Nausea 1 1
Pain 1 1
Respiratory Distress 1 1
Shock 1 1
Dizziness 1 1
Mitral Valve Prolapse 1 1
Hemorrhage/Bleeding 1 1

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