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TPLC
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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 Code
PHV
Regulation Number
862.2120
Device Class
1
Premarket Reviews
Manufacturer
Decision
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
Loss of Data
2
2
Application Program Problem
2
2
Data Problem
2
2
Unauthorized Access to Computer System
2
2
Device Displays Incorrect Message
1
1
Fluid/Blood Leak
1
1
Failure to Transmit Record
1
1
Patient Data Problem
1
1
Computer Operating System Problem
1
1
Calibration Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Low Readings
1
1
Product Quality Problem
1
1
Device Operates Differently Than Expected
1
1
Application Program Freezes, Becomes Nonfunctional
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
No Code Available
2
2
Nausea
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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