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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device turbidimetric method, triglycerides
Product CodeJGX
Regulation Number 862.1705
Device Class 1

MDR Year MDR Reports MDR Events
2022 4 4
2023 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Complete Blockage 4 4
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Fluid/Blood Leak 2 2
Fracture 1 1
Loose or Intermittent Connection 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Mechanics Altered 1 1
Disconnection 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Unspecified Tissue Injury 5 5
Unspecified Infection 3 3
Pain 1 1
Headache 1 1

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