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)
2019	2020	2021	2022	2023	2024
31	8	7	9	3	2

MDR Year	MDR Reports	MDR Events
2019	82390	83441
2020	77812	77812
2021	42577	42577
2022	54933	54933
2023	29740	29740
2024	9920	9920

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	33793	33793
Patient Device Interaction Problem	30110	30110
Obstruction of Flow	28284	28284
Pumping Stopped	27854	27854
Adverse Event Without Identified Device or Use Problem	25625	25625
Power Problem	23161	23161
Device Displays Incorrect Message	18016	18016
Mechanical Problem	16215	17266
No Display/Image	15745	15745
Battery Problem	14881	14881
Device Difficult to Program or Calibrate	14121	15172
Material Integrity Problem	13906	13906
Incorrect Measurement	13797	13797
Charging Problem	12746	12746
No Apparent Adverse Event	10679	10679
Appropriate Term/Code Not Available	10131	10131
Failure to Sense	9572	9572
Connection Problem	8050	8050
Physical Resistance/Sticking	6760	6760
Crack	6218	6218
Filling Problem	5840	5840
Communication or Transmission Problem	4859	4859
False Alarm	4828	4828
Device Alarm System	4389	4389
Display or Visual Feedback Problem	4165	4165
Moisture or Humidity Problem	4146	4146
Data Problem	4122	4122
Insufficient Flow or Under Infusion	3532	3532
Device Sensing Problem	3159	3159
Priming Problem	2855	2855
Date/Time-Related Software Problem	2741	2741
Incorrect, Inadequate or Imprecise Result or Readings	2428	2428
Poor Quality Image	2417	2417
Leak/Splash	2265	2265
Use of Device Problem	2262	2262
Detachment of Device or Device Component	2235	2235
Circuit Failure	1919	1919
Visual Prompts will not Clear	1775	1775
Failure to Cycle	1595	1595
Partial Blockage	1568	1568
Unexpected Therapeutic Results	1563	1563
Inappropriate or Unexpected Reset	1488	1488
Excess Flow or Over-Infusion	1407	1407
Insufficient Information	1299	1299
Loose or Intermittent Connection	1180	1180
Premature Discharge of Battery	961	961
Fitting Problem	876	876
Computer Software Problem	773	773
Electrical /Electronic Property Problem	762	762
Wireless Communication Problem	726	726

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	107295	108346
No Clinical Signs, Symptoms or Conditions	104950	104950
Hyperglycemia	31665	31665
No Known Impact Or Consequence To Patient	25763	25763
Insufficient Information	16213	16213
Hypoglycemia	12167	12167
Diabetic Ketoacidosis	3846	3846
Nausea	1056	1056
Vomiting	999	999
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	629	629
Loss of consciousness	585	585
Abdominal Pain	360	360
Dyspnea	294	294
Blood Loss	292	292
Death	271	271
Headache	247	247
Fatigue	247	247
Confusion/ Disorientation	219	219
Coma	192	192
No Patient Involvement	174	174
Polydipsia	171	171
Pain	165	165
Unspecified Tissue Injury	149	149
Dizziness	144	144
Foreign Body In Patient	139	139
Complaint, Ill-Defined	119	119
Seizures	116	116
Dehydration	105	105
Malaise	97	97
Shaking/Tremors	87	87
Chest Pain	82	82
Bruise/Contusion	81	81
Fall	80	80
Blurred Vision	74	74
Unspecified Infection	73	73
Renal Failure	60	60
Cardiac Arrest	57	57
Myocardial Infarction	57	57
Diarrhea	55	55
Pneumonia	52	52
Sweating	45	45
Skin Irritation	45	45
Stroke/CVA	43	43
Muscle Weakness	41	41
High Blood Pressure/ Hypertension	41	41
Urinary Frequency	40	40
Heart Failure/Congestive Heart Failure	38	38
Anxiety	37	37
Convulsion/Seizure	36	36
Bone Fracture(s)	36	36

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Inc.	II	Dec-02-2020
2	Medtronic Inc.	I	Feb-07-2020
3	Medtronic Inc.	II	Jul-09-2019
4	Medtronic MiniMed	II	Jul-08-2022