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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, ion based, enzymatic, creatinine
Product CodeCGL
Regulation Number 862.1225
Device Class 2

MDR Year MDR Reports MDR Events
2019 25 25
2020 19 19
2021 20 20
2022 11 11
2023 5 5
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 30 30
Non Reproducible Results 21 21
Incorrect Measurement 13 13
Low Test Results 10 10
Insufficient Information 3 3
Erratic Results 3 3
Low Readings 3 3
Defective Component 2 2
High Test Results 2 2
Smoking 1 1
Use of Device Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 30 30
No Consequences Or Impact To Patient 16 16
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 7 7
No Information 5 5
Abdominal Pain 2 2
Abnormal Blood Gases 2 2
Hematuria 2 2
Cancer 2 2
Death 1 1
Sepsis 1 1
No Code Available 1 1
Peripheral Vascular Disease 1 1
Cardiac Arrest 1 1
No Patient Involvement 1 1
Pain 1 1
Claudication 1 1
Cardiomyopathy 1 1
Sudden Cardiac Death 1 1
Premature Labor 1 1

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