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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
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 4 4
2021 5 5
2022 3 3
2023 29 29
2024 25 25
2025 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Non Reproducible Results 30 30
Low Test Results 30 30
High Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Chemical Problem 1 1
Output Problem 1 1
Contamination 1 1
Unable to Obtain Readings 1 1
Incorrect Measurement 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 70 70
No Known Impact Or Consequence To Patient 2 2
No Consequences Or Impact To Patient 2 2

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