TPLC - Total Product Life Cycle

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Device	integrated continuous glucose monitor for non-intensive glucose monitoring, over-the-counter
Regulation Description	Integrated continuous glucose monitoring system.
Definition	An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.
Product Code	SAF
Regulation Number	862.1355
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	1164	1164
Break	349	349
Appropriate Term/Code Not Available	157	157
Adverse Event Without Identified Device or Use Problem	90	90
Incorrect, Inadequate or Imprecise Result or Readings	35	35
Defective Device	11	11
Wireless Communication Problem	9	9
Device Sensing Problem	8	8
High Readings	6	6
Activation Failure	6	6
Therapeutic or Diagnostic Output Failure	5	5
Delivered as Unsterile Product	4	4
Low Readings	4	4
Activation, Positioning or Separation Problem	4	4
Unable to Obtain Readings	3	3
False Alarm	3	3
Display or Visual Feedback Problem	3	3
Unintended Electrical Shock	3	3
Product Quality Problem	2	2
Component Missing	2	2
No Audible Alarm	2	2
Patient Device Interaction Problem	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Activation Problem	2	2
Failure to Power Up	1	1
Difficult to Remove	1	1
Failure to Analyze Signal	1	1
Defective Alarm	1	1
Device Displays Incorrect Message	1	1
Application Program Version or Upgrade Problem	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1
Ejection Problem	1	1
Unintended Application Program Shut Down	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1377	1377
Foreign Body In Patient	271	271
Pain	108	108
Erythema	85	85
Skin Inflammation/ Irritation	69	69
Bacterial Infection	57	57
Insufficient Information	33	33
Hemorrhage/Bleeding	29	29
Abscess	29	29
Discomfort	20	20
Skin Infection	15	15
Itching Sensation	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Rash	13	13
Swelling/ Edema	11	11
Burning Sensation	11	11
Unspecified Infection	10	10
Cellulitis	9	9
Purulent Discharge	8	8
Hypersensitivity/Allergic reaction	8	8
Hypoglycemia	8	8
Foreign Body Reaction	7	7
Loss of consciousness	7	7
Blister	6	6
Malaise	5	5
Fluid Discharge	5	5
Bruise/Contusion	5	5
Skin Discoloration	4	4
Hyperglycemia	3	3
Anxiety	3	3
Inflammation	2	2
Fever	2	2
Fatigue	2	2
Device Embedded In Tissue or Plaque	2	2
Reaction to Medicinal Component of Device	1	1
Cognitive Changes	1	1
Confusion/ Disorientation	1	1
Skin Erosion	1	1
Dizziness	1	1
Drug Resistant Bacterial Infection	1	1
Abdominal Pain	1	1
Syncope/Fainting	1	1
Shaking/Tremors	1	1
Nodule	1	1
Sleep Dysfunction	1	1
Granuloma	1	1
Skin Burning Sensation	1	1