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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
Regulation Description Creatinine test system.
Product CodeCGL
Regulation Number 862.1225
Device Class 2

MDR Year MDR Reports MDR Events
2020 19 19
2021 20 20
2022 11 11
2023 5 5
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 24 24
Non Reproducible Results 18 18
Low Test Results 9 9
Erratic Results 3 3
Low Readings 3 3
Incorrect Measurement 3 3
Insufficient Information 3 3
Defective Component 2 2
High Test Results 2 2
Smoking 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 33 33
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 3 3
Abnormal Blood Gases 2 2
Ischemia Stroke 1 1
Death 1 1
Sepsis 1 1
Premature Labor 1 1
Cancer 1 1
Pain 1 1
Cardiac Arrest 1 1
No Information 1 1
Hematuria 1 1
Sudden Cardiac Death 1 1
Abdominal Pain 1 1
Cardiomyopathy 1 1

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