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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)
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
35
28
29
53
31
8
7
9
3
2
MDR Year
MDR Reports
MDR Events
2015
28763
28763
2016
21282
21282
2017
30435
30435
2018
39960
46990
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
Device Displays Incorrect Message
50994
52582
Break
39411
39411
Adverse Event Without Identified Device or Use Problem
38254
38254
Patient Device Interaction Problem
33276
33276
Obstruction of Flow
29643
29643
Pumping Stopped
28302
28302
No Display/Image
26359
26359
Power Problem
25190
25190
Mechanical Problem
17651
24144
Battery Problem
16921
16921
Device Difficult to Program or Calibrate
15098
16149
Material Integrity Problem
14191
14191
Incorrect Measurement
14125
14125
No Apparent Adverse Event
13597
13597
Charging Problem
12990
12990
Appropriate Term/Code Not Available
11889
11889
Failure to Sense
9774
9774
Crack
9086
9086
Connection Problem
8924
8924
Device Operates Differently Than Expected
8681
10269
Incorrect, Inadequate or Imprecise Result or Readings
7808
7808
Physical Resistance/Sticking
6823
6823
Insufficient Information
6768
6768
Device Alarm System
6481
6481
Filling Problem
6013
6013
Communication or Transmission Problem
5710
5710
Moisture or Humidity Problem
5468
5468
Display or Visual Feedback Problem
5034
5034
False Alarm
4939
4939
Device Inoperable
4570
4570
Bent
4375
4375
Insufficient Flow or Under Infusion
4340
4340
Data Problem
4238
4238
Component Missing
3713
3713
Incorrect Or Inadequate Test Results
3587
3587
Device Sensing Problem
3518
3518
Priming Problem
3271
3271
Failure to Deliver
3081
3081
Date/Time-Related Software Problem
2868
2868
Leak/Splash
2725
2725
Poor Quality Image
2686
2686
Use of Device Problem
2659
2659
Detachment of Device or Device Component
2635
2635
Visual Prompts will not Clear
2320
2320
Failure to Cycle
2120
2120
Circuit Failure
2078
2078
Excess Flow or Over-Infusion
2028
2028
Unexpected Therapeutic Results
1882
1882
Partial Blockage
1787
1787
Inappropriate or Unexpected Reset
1774
1774
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
140882
148963
No Clinical Signs, Symptoms or Conditions
104956
104956
Hyperglycemia
86608
86608
No Known Impact Or Consequence To Patient
44517
44517
Hypoglycemia
27493
27493
Insufficient Information
16214
16214
Diabetic Ketoacidosis
6845
6845
Vomiting
2052
2052
Nausea
1956
1956
Loss of consciousness
1083
1083
Death
907
907
Blood Loss
863
863
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
629
629
Abdominal Pain
551
551
Pain
536
536
Polydipsia
485
485
Headache
484
484
Fatigue
423
423
Dyspnea
419
419
Unspecified Infection
362
362
Seizures
355
355
No Information
345
345
Coma
331
331
Confusion/ Disorientation
318
318
Dehydration
299
299
Complaint, Ill-Defined
292
292
Dizziness
282
282
Hemorrhage/Bleeding
264
264
Underdose
257
257
Fall
233
233
Skin Irritation
227
227
Malaise
216
216
Urinary Frequency
208
208
No Code Available
195
195
Foreign Body In Patient
193
193
No Patient Involvement
189
189
Sweating
179
179
Chest Pain
166
166
Bruise/Contusion
166
166
Overdose
163
163
Shaking/Tremors
158
158
Unspecified Tissue Injury
149
149
Blurred Vision
121
121
Renal Failure
109
109
Myocardial Infarction
108
108
Swelling
101
101
Cardiac Arrest
99
99
Diarrhea
98
98
Pneumonia
97
97
Weakness
93
93
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 Inc.
II
Dec-22-2018
5
Medtronic Inc.
II
Feb-21-2018
6
Medtronic MiniMed
II
Jul-08-2022
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