TPLC - Total Product Life Cycle

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Device	sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Definition	A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.
Product Code	PZE
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
5	3	4	3	1	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	93759	93759
Unable to Obtain Readings	3659	3659
Device Displays Incorrect Message	3450	3450
High Readings	2550	2550
Low Readings	1963	1963
Application Program Problem	1281	1281
Appropriate Term/Code Not Available	1062	1062
Adverse Event Without Identified Device or Use Problem	1037	1037
Detachment of Device or Device Component	974	974
Product Quality Problem	894	894
Device Alarm System	634	634
Failure to Power Up	254	254
No Device Output	87	87
Material Twisted/Bent	49	49
Failure to Fire	46	46
Difficult to Insert	42	42
Premature Discharge of Battery	39	39
Computer Software Problem	33	33
Insufficient Information	32	32
Power Problem	23	23
Display or Visual Feedback Problem	19	19
Defective Device	18	18
Key or Button Unresponsive/not Working	16	16
Application Program Version or Upgrade Problem	15	15
Therapeutic or Diagnostic Output Failure	15	15
Battery Problem	15	15
Component Missing	15	15
Unintended Electrical Shock	14	14
No Display/Image	12	12
Output Problem	11	11
No Audible Alarm	10	10
Patient-Device Incompatibility	9	9
Break	9	9
Failure to Charge	9	9
Data Problem	9	9
Application Program Freezes, Becomes Nonfunctional	8	8
Crack	8	8
Packaging Problem	8	8
Patient Device Interaction Problem	7	7
Communication or Transmission Problem	7	7
Activation, Positioning or Separation Problem	7	7
Activation Failure	6	6
Connection Problem	5	5
Device Fell	5	5
Firing Problem	5	5
Display Difficult to Read	5	5
No Apparent Adverse Event	5	5
Device Sensing Problem	5	5
Compatibility Problem	5	5
Protective Measures Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	91398	91398
Hypoglycemia	5015	5015
No Known Impact Or Consequence To Patient	4224	4224
Loss of consciousness	4082	4082
Hyperglycemia	1965	1965
Convulsion/Seizure	1191	1191
Insufficient Information	916	916
Dizziness	892	892
Diaphoresis	780	780
Shaking/Tremors	655	655
Skin Irritation	617	617
Skin Infection	565	565
Pain	556	556
Itching Sensation	518	518
Erythema	502	502
Skin Inflammation/ Irritation	438	438
Unspecified Infection	435	435
Fatigue	388	388
Confusion/ Disorientation	341	341
Headache	311	311
Diabetic Ketoacidosis	298	298
Vomiting	296	296
Nausea	218	218
Purulent Discharge	206	206
Sweating	164	164
Swelling/ Edema	163	163
Muscle Weakness	158	158
Seizures	143	143
Malaise	125	125
Blurred Vision	123	123
Rash	121	121
Polydipsia	107	107
Hypersensitivity/Allergic reaction	107	107
Hemorrhage/Bleeding	93	93
Swelling	90	90
Discomfort	86	86
Device Embedded In Tissue or Plaque	82	82
Bruise/Contusion	80	80
No Information	74	74
Abscess	66	66
Fluid Discharge	65	65
Burn(s)	55	55
Fall	52	52
Coma	51	51
Lethargy	50	50
Weakness	50	50
Burning Sensation	46	46
Electric Shock	34	34
Dehydration	32	32
Skin Inflammation	32	32