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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device hexokinase, glucose
Product CodeCFR
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 10 10
2020 4 4
2021 5 5
2022 3 3
2023 29 29
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 34 34
Non Reproducible Results 30 30
High Test Results 21 21
Incorrect, Inadequate or Imprecise Result or Readings 7 7
No Apparent Adverse Event 2 2
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66 66
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 6 6

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