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	1

MDR Year	MDR Reports	MDR Events
2020	77812	77815
2021	42577	42591
2022	54924	54952
2023	29739	29756
2024	11814	11816
2025	3467	3467

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	34286	34289
Pumping Stopped	21570	21586
Obstruction of Flow	19634	19635
Power Problem	19207	19210
Patient Device Interaction Problem	18514	18514
Adverse Event Without Identified Device or Use Problem	16392	16394
Material Integrity Problem	13223	13225
No Display/Image	12264	12265
Battery Problem	11716	11717
Charging Problem	10585	10591
Mechanical Problem	10536	10536
Incorrect Measurement	9498	9502
Appropriate Term/Code Not Available	8656	8656
Device Displays Incorrect Message	7707	7707
Failure to Sense	7650	7661
Device Difficult to Program or Calibrate	7516	7516
Connection Problem	6177	6177
Physical Resistance/Sticking	5167	5167
No Apparent Adverse Event	4901	4902
Crack	4871	4884
Communication or Transmission Problem	4434	4442
Filling Problem	3875	3875
False Alarm	3770	3770
Moisture or Humidity Problem	3015	3015
Data Problem	2753	2754
Device Sensing Problem	2563	2564
Insufficient Flow or Under Infusion	2522	2522
Device Alarm System	2507	2507
Display or Visual Feedback Problem	2335	2335
Poor Quality Image	2234	2240
Date/Time-Related Software Problem	2157	2158
Leak/Splash	1626	1626
Priming Problem	1605	1605
Detachment of Device or Device Component	1390	1390
Circuit Failure	1358	1358
Use of Device Problem	1177	1177
Key or Button Unresponsive/not Working	1150	1150
Excess Flow or Over-Infusion	1137	1139
Inappropriate or Unexpected Reset	1126	1126
Incorrect, Inadequate or Imprecise Result or Readings	1094	1094
Loose or Intermittent Connection	1076	1077
Visual Prompts will not Clear	982	982
Insufficient Information	941	942
Unexpected Therapeutic Results	933	933
Partial Blockage	890	891
Failure to Cycle	748	748
Fitting Problem	668	668
Electrical /Electronic Property Problem	565	565
Computer Software Problem	563	563
Wireless Communication Problem	512	514

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	109354	109410
No Consequences Or Impact To Patient	54078	54078
Hyperglycemia	20730	20733
Insufficient Information	16551	16553
No Known Impact Or Consequence To Patient	12333	12335
Hypoglycemia	8083	8086
Diabetic Ketoacidosis	2594	2594
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	722	722
Nausea	663	663
Vomiting	635	635
Loss of consciousness	447	447
Fatigue	243	243
Abdominal Pain	221	221
Confusion/ Disorientation	210	210
Headache	204	204
Dyspnea	184	184
Unspecified Tissue Injury	150	151
Polydipsia	148	148
Coma	142	142
Death	136	136
Malaise	116	116
Pain	110	110
Dizziness	110	110
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
Renal Failure	59	59
Bruise/Contusion	59	59
Myocardial Infarction	58	58
Chest Pain	56	56
Unspecified Infection	52	52
Cardiac Arrest	49	49
Heart Failure/Congestive Heart Failure	47	47
Pneumonia	44	44
Stroke/CVA	40	40
Muscle Weakness	40	40
Diarrhea	38	38
Foreign Body In Patient	37	37
Convulsion/Seizure	36	36
Diaphoresis	36	36
Urinary Frequency	35	35
High Blood Pressure/ Hypertension	35	35
Anxiety	35	35
Convulsion, Clonic	30	30
Lethargy	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