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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

MDR Year MDR Reports MDR Events
2017 14 14
2018 11 11
2019 25 25
2020 19 19
2021 20 20
2022 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 37 37
Non Reproducible Results 21 21
Incorrect Measurement 13 13
Low Test Results 10 10
False Positive Result 5 5
Low Readings 3 3
Insufficient Information 3 3
Erratic Results 3 3
Adverse Event Without Identified Device or Use Problem 2 2
High Test Results 2 2
Fluid/Blood Leak 2 2
Use of Device Problem 2 2
Defective Component 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Display or Visual Feedback Problem 1 1
Application Program Problem: Dose Calculation Error 1 1
Device Displays Incorrect Message 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 22 22
No Consequences Or Impact To Patient 16 16
No Information 15 15
No Known Impact Or Consequence To Patient 11 11
Insufficient Information 9 9
Cancer 5 5
No Code Available 4 4
Death 3 3
Abnormal Blood Gases 2 2
Abdominal Pain 2 2
Hematuria 2 2
No Patient Involvement 1 1
Diabetic Ketoacidosis 1 1
Breast Mass 1 1
Premature Labor 1 1
Sudden Cardiac Death 1 1
Claudication 1 1
Apnea 1 1
Breast Cancer 1 1
Cardiac Arrest 1 1
Pain 1 1
Peripheral Vascular Disease 1 1
Transient Ischemic Attack 1 1

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