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)
2019	2020	2021	2022	2023	2024
1	0	0	0	0	1

MDR Year	MDR Reports	MDR Events
2019	44509	44509
2020	10579	10579
2021	4943	4943
2022	1378	1378
2023	6374	6374
2024	12748	12748

Device Problems	MDRs with this Device Problem	Events in those MDRs
Wireless Communication Problem	35359	35359
No Device Output	24055	24055
Communication or Transmission Problem	4015	4015
Imprecision	3905	3905
Premature End-of-Life Indicator	3517	3517
Detachment of Device or Device Component	2145	2145
Unable to Obtain Readings	2115	2115
Unexpected Shutdown	1847	1847
Display or Visual Feedback Problem	1532	1532
Appropriate Term/Code Not Available	1341	1341
Connection Problem	1163	1163
Unintended Application Program Shut Down	1098	1098
Defective Alarm	968	968
Calibration Problem	673	673
Inappropriate or Unexpected Reset	655	655
Device Displays Incorrect Message	611	611
Battery Problem	559	559
Incorrect, Inadequate or Imprecise Result or Readings	534	534
Break	525	525
No Audible Alarm	378	378
Adverse Event Without Identified Device or Use Problem	138	138
Overheating of Device	106	106
Low Audible Alarm	86	86
Application Program Freezes, Becomes Nonfunctional	84	84
Alarm Not Visible	80	80
Computer Software Problem	65	65
Failure of Device to Self-Test	59	59
Operating System Version or Upgrade Problem	42	42
Moisture or Humidity Problem	42	42
Use of Device Problem	30	30
Insufficient Information	14	14
Output Problem	11	11
Failure to Calibrate	7	7
Unexpected Therapeutic Results	6	6
Unintended Electrical Shock	6	6
Obstruction of Flow	5	5
Unintended Ejection	5	5
Manufacturing, Packaging or Shipping Problem	5	5
Packaging Problem	4	4
Device Alarm System	4	4
Arcing at Paddles	4	4
Retraction Problem	3	3
Failure to Sense	3	3
Delivered as Unsterile Product	2	2
Unauthorized Access to Computer System	2	2
Failure to Power Up	2	2
Patient Device Interaction Problem	2	2
Application Network Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Environmental Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	54309	54309
No Clinical Signs, Symptoms or Conditions	25027	25027
Hypoglycemia	395	395
Hyperglycemia	345	345
Hemorrhage/Bleeding	284	284
Loss of consciousness	167	167
Reaction	63	63
Diabetic Ketoacidosis	56	56
Pain	40	40
Erythema	39	39
Vomiting	38	38
Foreign Body In Patient	36	36
No Known Impact Or Consequence To Patient	35	35
Confusion/ Disorientation	29	29
Malaise	22	22
Discomfort	22	22
Fall	19	19
Sweating	19	19
Seizures	18	18
Dizziness	17	17
Skin Irritation	16	16
Itching Sensation	15	15
Blood Loss	15	15
Fatigue	14	14
Skin Inflammation/ Irritation	13	13
Nausea	12	12
Purulent Discharge	12	12
Insufficient Information	10	10
Shaking/Tremors	10	10
Injury	10	10
Rash	10	10
Swelling	9	9
Scarring	9	9
Weakness	9	9
Headache	8	8
Unspecified Infection	8	8
Collapse	7	7
Bruise/Contusion	6	6
Skin Inflammation	5	5
Burning Sensation	5	5
Lethargy	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Diaphoresis	5	5
Head Injury	5	5
Contusion	4	4
Cardiac Arrest	4	4
Blurred Vision	4	4
Hematoma	4	4
Coma	4	4
Electrolyte Imbalance	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Dexcom Inc	II	Mar-25-2020
2	Tandem Diabetes Care Inc	II	Sep-26-2022
3	Tandem Diabetes Care Inc	II	Jun-10-2022