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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bilirubin (total and unbound) in the neonate test system
Regulation Description Bilirubin (total and unbound) in the neonate test system.
Product CodeMQM
Regulation Number 862.1113
Device Class 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2023 14 14
2024 17 17
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 24 24
No Apparent Adverse Event 5 5
False Negative Result 2 2
Incorrect Measurement 2 2
Unexpected Therapeutic Results 2 2
Fitting Problem 1 1
Non Reproducible Results 1 1
Defective Component 1 1
Patient Data Problem 1 1
Low Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Jaundice 26 26
No Clinical Signs, Symptoms or Conditions 8 8
Insufficient Information 7 7

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