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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device enzyme immunoassay, digitoxin
Product CodeLFM
Regulation Number 862.3300
Device Class 2

MDR Year MDR Reports MDR Events
2017 11 11
2018 25 25
2019 2 2
2020 29 29
2021 25 25
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 72 72
High Test Results 9 9
Insufficient Information 8 8
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Incorrect Or Inadequate Test Results 2 2
No Apparent Adverse Event 2 2
High Readings 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 47 47
No Clinical Signs, Symptoms or Conditions 47 47
No Consequences Or Impact To Patient 1 1

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