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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 28 28
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
Adverse Event Without Identified Device or Use Problem 1 1
Use of Device Problem 1 1
Smoking 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 29 29
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
Hematuria 2 2
Cancer 2 2
Abnormal Blood Gases 2 2
Abdominal Pain 2 2
Cardiac Arrest 1 1
Death 1 1
Pain 1 1
Peripheral Vascular Disease 1 1
Premature Labor 1 1
Sudden Cardiac Death 1 1
Claudication 1 1
No Patient Involvement 1 1
No Code Available 1 1

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