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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 secondary display
Definition The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring
Product CodePJT
Regulation Number 862.1350
Device Class 2

MDR Year MDR Reports MDR Events
2021 9 9
2022 7 7
2023 2 2
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 8 8
Wireless Communication Problem 5 5
Device Alarm System 4 4
Application Program Problem 4 4
Compatibility Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Operating System Version or Upgrade Problem 1 1
Unintended Application Program Shut Down 1 1
Use of Device Problem 1 1
Data Problem 1 1
Product Quality Problem 1 1
Defective Alarm 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Insufficient Information 7 7
Hypoglycemia 4 4
Loss of consciousness 3 3
Confusion/ Disorientation 2 2
Convulsion/Seizure 2 2
Nausea 1 1
Brain Injury 1 1
Dizziness 1 1
Needle Stick/Puncture 1 1
Hyperglycemia 1 1
Pain 1 1

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