TPLC - Total Product Life Cycle

• Device: automated insulin dosing , threshold suspend
• Definition: An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
• Product Code: OZO
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
8	7	9	3	2	0

MDR Year	MDR Reports	MDR Events
2020	77812	77812
2021	42580	42580
2022	54935	54935
2023	29740	29740
2024	11813	11813
2025	2037	2037

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	33981	33981
Pumping Stopped	21565	21565
Obstruction of Flow	19307	19307
Power Problem	19098	19098
Patient Device Interaction Problem	18511	18511
Adverse Event Without Identified Device or Use Problem	16311	16311
Material Integrity Problem	12906	12906
No Display/Image	12128	12128
Battery Problem	11399	11399
Charging Problem	10577	10577
Mechanical Problem	10412	10412
Incorrect Measurement	9497	9497
Appropriate Term/Code Not Available	8616	8616
Device Displays Incorrect Message	7707	7707
Failure to Sense	7645	7645
Device Difficult to Program or Calibrate	7516	7516
Connection Problem	6167	6167
Physical Resistance/Sticking	5168	5168
No Apparent Adverse Event	4899	4899
Crack	4866	4866
Communication or Transmission Problem	4429	4429
Filling Problem	3874	3874
False Alarm	3769	3769
Moisture or Humidity Problem	2951	2951
Data Problem	2753	2753
Device Sensing Problem	2558	2558
Insufficient Flow or Under Infusion	2487	2487
Device Alarm System	2484	2484
Display or Visual Feedback Problem	2296	2296
Poor Quality Image	2228	2228
Date/Time-Related Software Problem	2148	2148
Leak/Splash	1626	1626
Priming Problem	1585	1585
Detachment of Device or Device Component	1381	1381
Circuit Failure	1351	1351
Use of Device Problem	1174	1174
Excess Flow or Over-Infusion	1128	1128
Inappropriate or Unexpected Reset	1126	1126
Loose or Intermittent Connection	1076	1076
Incorrect, Inadequate or Imprecise Result or Readings	1036	1036
Visual Prompts will not Clear	982	982
Key or Button Unresponsive/not Working	966	966
Unexpected Therapeutic Results	928	928
Insufficient Information	927	927
Partial Blockage	890	890
Failure to Cycle	741	741
Fitting Problem	668	668
Computer Software Problem	558	558
Electrical /Electronic Property Problem	556	556
Wireless Communication Problem	501	501

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	108140	108140
No Consequences Or Impact To Patient	54078	54078
Hyperglycemia	20591	20591
Insufficient Information	16544	16544
No Known Impact Or Consequence To Patient	12333	12333
Hypoglycemia	8014	8014
Diabetic Ketoacidosis	2583	2583
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	717	717
Nausea	662	662
Vomiting	634	634
Loss of consciousness	444	444
Fatigue	237	237
Abdominal Pain	220	220
Confusion/ Disorientation	208	208
Headache	201	201
Dyspnea	184	184
Unspecified Tissue Injury	150	150
Polydipsia	147	147
Coma	141	141
Death	136	136
Malaise	112	112
Dizziness	109	109
Pain	108	108
Blood Loss	86	86
Shaking/Tremors	80	80
Complaint, Ill-Defined	70	70
Blurred Vision	68	68
Fall	68	68
No Patient Involvement	68	68
Dehydration	65	65
Seizures	64	64
Bruise/Contusion	58	58
Myocardial Infarction	56	56
Renal Failure	56	56
Chest Pain	56	56
Unspecified Infection	52	52
Cardiac Arrest	47	47
Heart Failure/Congestive Heart Failure	44	44
Pneumonia	43	43
Stroke/CVA	40	40
Muscle Weakness	40	40
Diarrhea	38	38
Foreign Body In Patient	37	37
Convulsion/Seizure	36	36
Anxiety	35	35
High Blood Pressure/ Hypertension	35	35
Diaphoresis	35	35
Urinary Frequency	34	34
Convulsion, Clonic	29	29
Bone Fracture(s)	28	28

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc.	II	Dec-02-2020
2	Medtronic Inc.	I	Feb-07-2020
3	Medtronic MiniMed	II	Jul-08-2022
4	Medtronic MiniMed, Inc.	II	Mar-03-2025
5	Medtronic MiniMed, Inc.	I	Oct-03-2024