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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, digoxin
Product CodeKXT
Regulation Number 862.3320
Device Class 2


Premarket Reviews
ManufacturerDecision
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 5 5
2021 1 1
2022 3 3
2023 5 5
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 7 7
Low Test Results 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Unexpected Therapeutic Results 2 2
Incorrect Measurement 2 2
Non Reproducible Results 2 2
Mechanical Problem 1 1
Unable to Obtain Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Consequences Or Impact To Patient 4 4
Death 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1

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