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	1357	1357
Break	412	412
Appropriate Term/Code Not Available	230	230
Adverse Event Without Identified Device or Use Problem	104	104
Incorrect, Inadequate or Imprecise Result or Readings	51	51
High Readings	18	18
Wireless Communication Problem	17	17
Device Sensing Problem	12	12
Unintended Electrical Shock	12	12
Defective Device	12	12
Therapeutic or Diagnostic Output Failure	10	10
Low Readings	8	8
Activation Failure	6	6
Unexpected Shutdown	6	6
Delivered as Unsterile Product	5	5
Unable to Obtain Readings	5	5
Product Quality Problem	4	4
Activation, Positioning or Separation Problem	4	4
Patient Device Interaction Problem	3	3
False Alarm	3	3
Display or Visual Feedback Problem	3	3
No Audible Alarm	2	2
Component Missing	2	2
Activation Problem	2	2
Protective Measures Problem	2	2
Application Program Freezes, Becomes Nonfunctional	2	2
Connection Problem	2	2
Overheating of Device	2	2
Device Displays Incorrect Message	2	2
Difficult to Remove	1	1
Ejection Problem	1	1
Unintended Application Program Shut Down	1	1
Failure to Power Up	1	1
Unsealed Device Packaging	1	1
Insufficient Information	1	1
Packaging Problem	1	1
Application Program Version or Upgrade Problem	1	1
Application Program Problem	1	1
Image Display Error/Artifact	1	1
No Apparent Adverse Event	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Defective Alarm	1	1
Failure to Analyze Signal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1666	1666
Foreign Body In Patient	329	329
Pain	133	133
Erythema	102	102
Skin Inflammation/ Irritation	75	75
Bacterial Infection	68	68
Hemorrhage/Bleeding	39	39
Insufficient Information	38	38
Abscess	34	34
Discomfort	22	22
Skin Infection	20	20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	18	18
Itching Sensation	17	17
Rash	17	17
Swelling/ Edema	14	14
Foreign Body Reaction	13	13
Hypoglycemia	12	12
Burning Sensation	12	12
Loss of consciousness	11	11
Cellulitis	10	10
Unspecified Infection	10	10
Purulent Discharge	9	9
Hypersensitivity/Allergic reaction	8	8
Blister	7	7
Fluid Discharge	7	7
Malaise	6	6
Nodule	5	5
Bruise/Contusion	5	5
Skin Discoloration	4	4
Anxiety	4	4
Hyperglycemia	3	3
Syncope/Fainting	3	3
Fever	2	2
Inflammation	2	2
Fatigue	2	2
Shaking/Tremors	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
Needle Stick/Puncture	1	1
Dizziness	1	1
Numbness	1	1
Drug Resistant Bacterial Infection	1	1
Sleep Dysfunction	1	1
Abdominal Pain	1	1
Granuloma	1	1
Skin Burning Sensation	1	1