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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device electrode, ion based, enzymatic, creatinine
Regulation Description Creatinine test system.
Product CodeCGL
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 2 2
2017 14 14
2018 11 11
2019 25 25
2020 19 19
2021 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 32 32
Non Reproducible Results 21 21
Incorrect Measurement 13 13
False Positive Result 5 5
Low Test Results 5 5
Low Readings 3 3
Insufficient Information 3 3
Erratic Results 3 3
Use of Device Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Displays Incorrect Message 1 1
Application Program Problem: Dose Calculation Error 1 1
Electrical /Electronic Property Problem 1 1
Device Stops Intermittently 1 1
Defective Component 1 1
High Test Results 1 1
Incorrect Or Inadequate Test Results 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1
Fluid Leak 1 1
Display or Visual Feedback Problem 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 17 17
No Information 16 16
No Clinical Signs, Symptoms or Conditions 13 13
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 7 7
Cancer 5 5
No Code Available 4 4
Death 3 3
Abnormal Blood Gases 2 2
Hematuria 2 2
Transient Ischemic Attack 1 1
Sudden Cardiac Death 1 1
Claudication 1 1
Abdominal Pain 1 1
Apnea 1 1
Breast Cancer 1 1
Cardiac Arrest 1 1
Pain 1 1
Peripheral Vascular Disease 1 1
Diabetic Ketoacidosis 1 1
Breast Mass 1 1
Premature Labor 1 1
No Patient Involvement 1 1

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