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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device continuous glucose monitor retrospective data analysis software
Definition Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.
Product CodePHV
Regulation Number 862.2120
Device Class 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2021 5 5
2022 674 674
2023 820 820
2024 214 214

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1625 1625
Wireless Communication Problem 101 101
Appropriate Term/Code Not Available 55 55
Problem with Software Installation 15 15
Communication or Transmission Problem 15 15
No Apparent Adverse Event 14 14
Application Network Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Unauthorized Access to Computer System 2 2
Loss of Data 2 2
Application Program Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Computer Operating System Problem 1 1
Calibration Problem 1 1
Patient Data Problem 1 1
Failure to Transmit Record 1 1
Product Quality Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1596 1596
Insufficient Information 109 109
Hyperglycemia 6 6
No Known Impact Or Consequence To Patient 4 4
Hypoglycemia 3 3
Syncope 1 1
Nausea 1 1
Shaking/Tremors 1 1
Loss of consciousness 1 1
Distress 1 1

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