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)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
0	0	0	0	0	0	0	1	3	2	1	0	0	0	0	1

MDR Year	MDR Reports	MDR Events
2016	3	3
2017	65176	65176
2018	116245	116245
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	108993	108993
Imprecision	51355	51355
Device Displays Incorrect Message	28078	28078
No Device Output	25217	25217
Use of Device Problem	24262	24262
Invalid Sensing	6721	6721
Premature End-of-Life Indicator	4966	4966
Unable to Obtain Readings	4084	4084
Defective Alarm	4067	4067
Communication or Transmission Problem	4047	4047
Device Inoperable	3759	3759
Inappropriate or Unexpected Reset	3442	3442
Detachment of Device or Device Component	2965	2965
Unexpected Shutdown	2846	2846
Device Operates Differently Than Expected	2209	2209
Display or Visual Feedback Problem	1969	1969
Low Battery	1878	1878
Appropriate Term/Code Not Available	1701	1701
Connection Problem	1593	1593
Component Missing	1319	1319
Unintended Application Program Shut Down	1316	1316
No Audible Alarm	1083	1083
Detachment Of Device Component	984	984
Break	891	891
Adverse Event Without Identified Device or Use Problem	755	755
Calibration Problem	675	675
Battery Problem	575	575
Incorrect, Inadequate or Imprecise Result or Readings	537	537
Overheating of Device	411	411
Application Program Freezes, Becomes Nonfunctional	173	173
Low Audible Alarm	160	160
Alarm Not Visible	120	120
Output Problem	101	101
Computer Software Problem	66	66
Failure of Device to Self-Test	59	59
Operating System Version or Upgrade Problem	57	57
Moisture or Humidity Problem	42	42
Insufficient Information	33	33
Environmental Particulates	30	30
Retraction Problem	27	27
Failure to Calibrate	19	19
Failure to Power Up	18	18
Gel Leak	17	17
Unintended Electrical Shock	15	15
Calibration Error	15	15
Disconnection	13	13
Device Issue	13	13
Incomplete or Inadequate Connection	11	11
Failure to Sense	11	11
Unexpected Therapeutic Results	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	232660	232660
No Clinical Signs, Symptoms or Conditions	25038	25038
No Known Impact Or Consequence To Patient	1684	1684
Hypoglycemia	1039	1039
Hyperglycemia	445	445
Loss of consciousness	426	426
Reaction	357	357
Hemorrhage/Bleeding	287	287
Erythema	218	218
Itching Sensation	149	149
Pain	118	118
Foreign Body In Patient	117	117
Seizures	106	106
Diabetic Ketoacidosis	105	105
Scarring	99	99
Malaise	94	94
Blood Loss	92	92
Confusion/ Disorientation	90	90
Skin Irritation	89	89
Vomiting	76	76
Rash	66	66
Sweating	60	60
Dizziness	57	57
Discomfort	56	56
Shaking/Tremors	53	53
Swelling	50	50
Purulent Discharge	50	50
Fall	44	44
Injury	41	41
Unspecified Infection	39	39
Skin Discoloration	31	31
Skin Inflammation	28	28
Nausea	26	26
Bruise/Contusion	20	20
Burning Sensation	20	20
Fatigue	20	20
Weakness	19	19
Lethargy	17	17
Coma	16	16
Collapse	15	15
Fainting	15	15
Headache	14	14
Urticaria	14	14
Skin Inflammation/ Irritation	13	13
Dehydration	12	12
Inflammation	11	11
Fluid Discharge	11	11
Insufficient Information	11	11
Cognitive Changes	8	8
Death	8	8

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