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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device laboratory developed test
Definition Laboratory Developed Test
Product CodeOQS
Device Class Not Classified

MDR Year MDR Reports MDR Events
2014 1 1
2015 1 1
2016 2 2
2023 5 5
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 4 4
False Positive Result 3 3
False Negative Result 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Miscarriage 1 1
Breast Cancer 1 1
No Known Impact Or Consequence To Patient 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
No Patient Involvement 1 1
Suicidal Ideation 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Congenital Defect/Deformity 1 1

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