TPLC - Total Product Life Cycle

• Device: continuous glucose monitor retrospective data analysis software
• Regulation Description: Continuous glucose monitor data management system.
• 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

MDR Year	MDR Reports	MDR Events
2020	1	1
2021	4	5
2022	674	674
2023	820	820
2024	284	284
2025	148	148

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	1728	1728
Data Problem	113	113
Wireless Communication Problem	110	110
Appropriate Term/Code Not Available	62	62
Communication or Transmission Problem	17	17
Problem with Software Installation	15	15
No Apparent Adverse Event	14	14
Unauthorized Access to Computer System	5	5
Application Network Problem	5	5
Application Program Problem	4	5
Device-Device Incompatibility	1	1
Failure to Transmit Record	1	2
Patient Data Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	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
Loss of Data	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1810	1810
Insufficient Information	109	110
Hyperglycemia	6	6
Hypoglycemia	4	4
Loss of consciousness	2	2
Nausea	1	1
Shaking/Tremors	1	1
Hemorrhage/Bleeding	1	1
Distress	1	1