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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 136 136

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1558 1558
Wireless Communication Problem 89 89
Appropriate Term/Code Not Available 45 45
No Apparent Adverse Event 14 14
Communication or Transmission Problem 14 14
Problem with Software Installation 13 13
Application Network Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Loss of Data 2 2
Unauthorized Access to Computer System 2 2
Application Program Freezes, Becomes Nonfunctional 1 1
Failure to Transmit Record 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Calibration Problem 1 1
Patient Data Problem 1 1
Application Program Problem 1 1
Computer Operating System Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1518 1518
Insufficient Information 109 109
Hyperglycemia 6 6
No Known Impact Or Consequence To Patient 4 4
Hypoglycemia 3 3
Nausea 1 1
Distress 1 1
Loss of consciousness 1 1
Shaking/Tremors 1 1
Syncope 1 1

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