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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hexokinase, glucose
Regulation Description Glucose test system.
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT IRELAND
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 3 3
2023 29 30
2024 15 15
2025 16 16
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 30 31
Low Test Results 30 31
High Test Results 22 22
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Incorrect Measurement 5 5
Output Problem 2 2
Material Integrity Problem 1 1
Unable to Obtain Readings 1 1
No Apparent Adverse Event 1 1
Contamination 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 81 82

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