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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device enzyme immunoassay, digitoxin
Product CodeLFM
Regulation Number 862.3300
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 29 29
2021 25 25
2022 3 3
2023 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 67 67
High Test Results 9 9
Insufficient Information 8 8
No Apparent Adverse Event 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 74 74
No Known Impact Or Consequence To Patient 12 12

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