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TPLC
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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
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