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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 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Low Test Results 32 32
Non Reproducible Results 27 27
High Test Results 19 19
Incorrect, Inadequate or Imprecise Result or Readings 7 7
Incorrect Measurement 2 2
Chemical Problem 1 1
Output Problem 1 1
Contamination 1 1
Unable to Obtain Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 60 60
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 6 6

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