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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
42579
42579
2022
54935
54935
2023
29740
29740
2024
11813
11813
2025
506
506
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
33608
33608
Pumping Stopped
21431
21431
Power Problem
19028
19028
Obstruction of Flow
19009
19009
Patient Device Interaction Problem
18508
18508
Adverse Event Without Identified Device or Use Problem
16235
16235
Material Integrity Problem
12767
12767
No Display/Image
12039
12039
Battery Problem
11216
11216
Charging Problem
10518
10518
Mechanical Problem
10313
10313
Incorrect Measurement
9470
9470
Appropriate Term/Code Not Available
8503
8503
Device Displays Incorrect Message
7707
7707
Failure to Sense
7617
7617
Device Difficult to Program or Calibrate
7516
7516
Connection Problem
6159
6159
Physical Resistance/Sticking
5167
5167
No Apparent Adverse Event
4899
4899
Crack
4845
4845
Communication or Transmission Problem
4404
4404
Filling Problem
3863
3863
False Alarm
3752
3752
Moisture or Humidity Problem
2931
2931
Data Problem
2748
2748
Device Sensing Problem
2528
2528
Device Alarm System
2470
2470
Insufficient Flow or Under Infusion
2459
2459
Display or Visual Feedback Problem
2272
2272
Poor Quality Image
2206
2206
Date/Time-Related Software Problem
2143
2143
Leak/Splash
1623
1623
Priming Problem
1569
1569
Detachment of Device or Device Component
1372
1372
Circuit Failure
1348
1348
Use of Device Problem
1169
1169
Inappropriate or Unexpected Reset
1124
1124
Excess Flow or Over-Infusion
1117
1117
Loose or Intermittent Connection
1075
1075
Incorrect, Inadequate or Imprecise Result or Readings
1035
1035
Visual Prompts will not Clear
982
982
Unexpected Therapeutic Results
925
925
Insufficient Information
914
914
Partial Blockage
889
889
Key or Button Unresponsive/not Working
837
837
Failure to Cycle
736
736
Fitting Problem
668
668
Computer Software Problem
551
551
Electrical /Electronic Property Problem
550
550
Loss of Data
499
499
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
106886
106886
No Consequences Or Impact To Patient
54078
54078
Hyperglycemia
20463
20463
Insufficient Information
16440
16440
No Known Impact Or Consequence To Patient
12333
12333
Hypoglycemia
7979
7979
Diabetic Ketoacidosis
2564
2564
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
690
690
Nausea
662
662
Vomiting
632
632
Loss of consciousness
443
443
Fatigue
235
235
Abdominal Pain
220
220
Confusion/ Disorientation
206
206
Headache
200
200
Dyspnea
184
184
Unspecified Tissue Injury
150
150
Polydipsia
147
147
Coma
141
141
Death
136
136
Malaise
108
108
Dizziness
107
107
Pain
106
106
Blood Loss
86
86
Shaking/Tremors
80
80
Complaint, Ill-Defined
70
70
Fall
68
68
No Patient Involvement
68
68
Blurred Vision
67
67
Seizures
64
64
Dehydration
63
63
Bruise/Contusion
57
57
Chest Pain
56
56
Renal Failure
54
54
Myocardial Infarction
54
54
Unspecified Infection
52
52
Cardiac Arrest
47
47
Pneumonia
42
42
Heart Failure/Congestive Heart Failure
41
41
Muscle Weakness
40
40
Stroke/CVA
40
40
Diarrhea
38
38
Foreign Body In Patient
37
37
Convulsion/Seizure
36
36
Anxiety
35
35
Diaphoresis
35
35
High Blood Pressure/ Hypertension
34
34
Urinary Frequency
33
33
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.
I
Oct-03-2024
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