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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device titrimetric with edta and indicator, calcium
Regulation Description Calcium test system.
Product CodeCHW
Regulation Number 862.1145
Device Class 2

MDR Year MDR Reports MDR Events
2021 7 7
2022 4 4
2023 22 23
2024 23 25
2025 22 22
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 40 41
Low Test Results 30 33
Incorrect, Inadequate or Imprecise Result or Readings 23 24
High Test Results 23 23
Output Problem 4 4
Incorrect Measurement 3 3
Unable to Obtain Readings 2 2
Optical Problem 2 2
Mechanical Problem 1 2
High Readings 1 1
Insufficient Device Problem Information 1 1
Calibration Problem 1 1
False Positive Result 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 93 96
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1

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