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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
2018 11 11
2019 25 25
2020 19 19
2021 20 20
2022 11 11
2023 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Non Reproducible Results 21 21
Incorrect Measurement 13 13
Low Test Results 10 10
High Test Results 4 4
Low Readings 3 3
Erratic Results 3 3
Insufficient Information 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Defective Component 2 2
Fluid/Blood Leak 1 1
Smoking 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27 27
No Consequences Or Impact To Patient 16 16
No Information 10 10
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 9 9
No Code Available 3 3
Cancer 3 3
Hematuria 2 2
Abnormal Blood Gases 2 2
Abdominal Pain 2 2
Death 1 1
Peripheral Vascular Disease 1 1
Sudden Cardiac Death 1 1
Breast Cancer 1 1
No Patient Involvement 1 1
Cardiac Arrest 1 1
Pain 1 1
Premature Labor 1 1
Apnea 1 1
Transient Ischemic Attack 1 1
Claudication 1 1

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