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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
2018 5 5
2019 5 5
2020 1 1
2021 5 5
2022 674 674
2023 744 744

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 1367 1367
Wireless Communication Problem 55 55
Appropriate Term/Code Not Available 29 29
Communication or Transmission Problem 14 14
No Apparent Adverse Event 14 14
Problem with Software Installation 12 12
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Application Program Problem 2 2
Unauthorized Access to Computer System 2 2
Loss of Data 2 2
Data Problem 2 2
Patient Data Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Device Operates Differently Than Expected 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Calibration Problem 1 1
Computer Operating System Problem 1 1
Low Readings 1 1
Application Network Problem 1 1
Product Quality Problem 1 1
Failure to Transmit Record 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1307 1307
Insufficient Information 109 109
Hyperglycemia 6 6
No Known Impact Or Consequence To Patient 6 6
Hypoglycemia 3 3
Nausea 2 2
No Code Available 2 2
Syncope 1 1
Abdominal Pain 1 1
Distress 1 1
Loss of consciousness 1 1
Shaking/Tremors 1 1

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