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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
Product CodeCGL
Regulation Number 862.1225
Device Class 2


Premarket Reviews
ManufacturerDecision
NOVA BIOMEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  1.  K171059  Nova StatSensor Creatinine Hospital Meter System

MDR Year MDR Reports MDR Events
2017 14 14
2018 11 11
2019 25 25
2020 19 19
2021 20 20
2022 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Resultor Readings 34 34
Non Reproducible Results 21 21
Incorrect Measurement 13 13
Low Test Results 9 9
False Positive Result 5 5
Low Readings 3 3
Insufficient Information 3 3
Erratic Results 3 3
Use of Device Problem 2 2
Fluid Leak 2 2
High Test Results 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Application Program Problem: Dose Calculation Error 1 1
Device Displays Incorrect Message 1 1
Display or Visual Feedback Problem 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Defective Component 1 1
Device Operates Differently Than Expected 1 1
Device Operational Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 20 20
No Consequences Or Impact To Patient 16 16
No Information 15 15
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 8 8
Cancer 5 5
No Code Available 4 4
Death 3 3
Abnormal Blood Gases 2 2
Hematuria 2 2
Sudden Cardiac Death 1 1
Breast Cancer 1 1
Cardiac Arrest 1 1
Pain 1 1
Diabetic Ketoacidosis 1 1
Premature Labor 1 1
No Patient Involvement 1 1
Abdominal Pain 1 1
Apnea 1 1
Peripheral Vascular Disease 1 1
Breast Mass 1 1
Transient Ischemic Attack 1 1
Claudication 1 1

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