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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 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 5 5
2022 3 3
2023 29 30
2024 15 15
2025 18 18
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 32 33
Non Reproducible Results 28 29
High Test Results 22 22
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Incorrect Measurement 2 2
Output Problem 1 1
Material Integrity Problem 1 1
Contamination 1 1
Unable to Obtain Readings 1 1
Low Readings 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 73 74
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2

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