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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


Premarket Reviews
ManufacturerDecision
DEXCOM, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2017 1 1
2018 5 5
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 1626 1626
Wireless Communication Problem 101 101
Appropriate Term/Code Not Available 55 55
Communication or Transmission Problem 16 16
Problem with Software Installation 15 15
No Apparent Adverse Event 14 14
Application Network Problem 5 5
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Application Program Problem 2 2
Unauthorized Access to Computer System 2 2
Data Problem 2 2
Loss of Data 2 2
Failure to Transmit Record 1 1
Patient Data Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Calibration Problem 1 1
Computer Operating System Problem 1 1
Product Quality Problem 1 1
Low Readings 1 1
Device Operates Differently Than Expected 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Device Displays Incorrect Message 1 1
Fluid/Blood Leak 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 7 7
No Known Impact Or Consequence To Patient 6 6
Hypoglycemia 3 3
Nausea 2 2
No Code Available 2 2
Abdominal Pain 1 1
Syncope 1 1
Shaking/Tremors 1 1
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1
Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Sep-27-2016
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