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 Code	PJT
Regulation Number	862.1350
Device Class	2

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
Defective Alarm	1	1
Unintended Application Program Shut Down	1	1
Imprecision	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Use of Device Problem	1	1
Component Missing	1	1
Application Program Problem	1	1
Computer Operating System Problem	1	1
Device Operates Differently Than Expected	1	1
Compatibility Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Operating System Version or Upgrade Problem	1	1
Data Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	12	12
Insufficient Information	6	6
Hyperglycemia	1	1
Hypoglycemia	1	1
No Consequences Or Impact To Patient	1	1
No Known Impact Or Consequence To Patient	1	1
No Information	1	1