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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device albumin, antigen, antiserum, control
Regulation Description Albumin immunological test system.
Product CodeDCF
Regulation Number 866.5040
Device Class 2

MDR Year MDR Reports MDR Events
2021 3 4
2022 3 3
2023 5 5
2024 9 9
2025 12 12
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 27 27
High Test Results 14 15
Non Reproducible Results 10 10
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Incorrect Measurement 3 3
Device Handling Problem 1 1
Infusion or Flow Problem 1 1
Unable to Obtain Readings 1 1
High Readings 1 2
Insufficient Device Problem Information 1 1
Material Integrity Problem 1 1
Device Alarm System 1 1
Signal Artifact/Noise 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 50
Unspecified Eye / Vision Problem 1 1

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