TPLC - Total Product Life Cycle

• Device: sensor, glucose, invasive, non-adjunctive
• Definition: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
• Product Code: PQF
• Device Class: 3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	0	0	2	0	0

MDR Year	MDR Reports	MDR Events
2021	4943	4945
2022	1378	1383
2023	6373	6382
2024	22389	22394
2025	38635	38645
2026	11564	11564

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	76742	76758
No Device Output	4483	4483
Communication or Transmission Problem	4080	4085
Display or Visual Feedback Problem	3497	3497
Incorrect, Inadequate or Imprecise Result or Readings	2909	2909
Battery Problem	2398	2399
Calibration Problem	1850	1850
Appropriate Term/Code Not Available	1122	1123
Break	282	282
Connection Problem	261	261
Unexpected Therapeutic Results	236	236
Retraction Problem	217	217
Inappropriate or Unexpected Reset	206	206
Computer Software Problem	180	180
Imprecision	158	158
Premature End-of-Life Indicator	102	102
Moisture or Humidity Problem	85	85
Material Integrity Problem	77	77
Delayed Alarm	59	69
Failure of Device to Self-Test	59	59
Detachment of Device or Device Component	57	58
Unintended Application Program Shut Down	56	56
Activation Problem	40	40
Material Twisted/Bent	38	38
Unable to Obtain Readings	33	33
Use of Device Problem	30	30
Operating System Version or Upgrade Problem	23	23
Delivered as Unsterile Product	21	21
Loss of or Failure to Bond	20	20
Device Alarm System	18	18
Adverse Event Without Identified Device or Use Problem	17	17
Packaging Problem	17	17
Device Difficult to Program or Calibrate	16	16
Manufacturing, Packaging or Shipping Problem	14	14
Failure to Fire	12	12
Obstruction of Flow	11	11
Patient Device Interaction Problem	10	10
Difficult to Remove	10	10
Unauthorized Access to Computer System	10	10
No Audible Alarm	8	8
Physical Resistance/Sticking	8	8
Unexpected Shutdown	8	8
Application Network Problem	8	8
Product Quality Problem	6	6
Firing Problem	6	6
Data Problem	5	5
Overheating of Device	5	5
Fracture	4	4
Activation, Positioning or Separation Problem	4	4
Inaccurate Synchronization	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81002	81029
Hemorrhage/Bleeding	1727	1727
Hyperglycemia	1644	1646
Hypoglycemia	737	737
Skin Inflammation/ Irritation	73	73
Pain	71	71
Diabetic Ketoacidosis	67	67
Bruise/Contusion	43	43
No Consequences Or Impact To Patient	39	39
Insufficient Information	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	33	33
Malaise	30	30
Discomfort	28	28
Vomiting	26	26
Itching Sensation	26	26
Erythema	18	18
Needle Stick/Puncture	18	18
Rash	17	17
Loss of consciousness	16	16
Fatigue	15	15
Nausea	15	15
Diaphoresis	15	15
Foreign Body In Patient	14	14
Headache	11	11
Unspecified Infection	11	11
Hypersensitivity/Allergic reaction	11	11
Hematoma	11	11
Skin Infection	9	9
Confusion/ Disorientation	9	9
Polydipsia	6	6
Dizziness	6	6
Swelling/ Edema	5	5
Respiratory Tract Infection	4	4
Dehydration	4	4
Purulent Discharge	4	4
Coma	4	4
Convulsion, Clonic	4	4
Abdominal Pain	4	4
Cardiac Arrest	3	3
Cellulitis	3	3
Electrolyte Imbalance	3	3
Cramp(s) /Muscle Spasm(s)	3	3
Fever	3	3
Dyspnea	3	3
Convulsion/Seizure	3	3
Hypoglycemic Shock	3	3
Injection Site Reaction	3	3
Syncope/Fainting	3	3
Shaking/Tremors	3	3
Scar Tissue	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Tandem Diabetes Care Inc	II	Sep-26-2022
2	Tandem Diabetes Care Inc	II	Jun-10-2022