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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 170 170

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1586 1586
Wireless Communication Problem 98 98
Appropriate Term/Code Not Available 49 49
Communication or Transmission Problem 15 15
Problem with Software Installation 14 14
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
Product Quality Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Failure to Transmit Record 1 1
Adverse Event Without Identified Device or Use 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 1552 1552
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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