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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 photometric method, ammonia
Product CodeJID
Regulation Number 862.1065
Device Class 1

MDR Year MDR Reports MDR Events
2017 8 8
2018 6 6
2019 13 13
2020 26 26
2021 19 19
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 40 40
Low Test Results 13 13
Incorrect, Inadequate or Imprecise Resultor Readings 10 10
Adverse Event Without Identified Device or Use Problem 7 7
High Readings 5 5
Incorrect Or Inadequate Test Results 3 3
Low Readings 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
No Known Impact Or Consequence To Patient 28 28
No Consequences Or Impact To Patient 10 10

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