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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)
2018
2019
2020
2021
2022
2023
53
31
8
7
9
2
MDR Year
MDR Reports
MDR Events
2018
39960
46990
2019
82390
83441
2020
77812
77812
2021
42586
42586
2022
54977
54977
2023
14490
14490
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient Device Interaction Problem
33252
33252
Adverse Event Without Identified Device or Use Problem
30642
30642
Break
28853
28853
Obstruction of Flow
26521
26521
Pumping Stopped
25466
25466
Device Displays Incorrect Message
23270
24858
Power Problem
21734
21734
No Display/Image
18296
18296
Mechanical Problem
16039
22532
Device Difficult to Program or Calibrate
14503
15554
No Apparent Adverse Event
13594
13594
Battery Problem
13476
13476
Material Integrity Problem
13439
13439
Incorrect Measurement
12878
12878
Charging Problem
11480
11480
Connection Problem
8469
8469
Failure to Sense
8209
8209
Appropriate Term/Code Not Available
7437
7437
Physical Resistance/Sticking
6825
6825
Crack
6163
6163
Filling Problem
5720
5720
Device Alarm System
4912
4912
Display or Visual Feedback Problem
4675
4675
Communication or Transmission Problem
4626
4626
False Alarm
4464
4464
Incorrect, Inadequate or Imprecise Result or Readings
4190
4190
Moisture or Humidity Problem
4059
4059
Data Problem
4006
4006
Insufficient Flow or Under Infusion
3655
3655
Priming Problem
3030
3030
Device Sensing Problem
2605
2605
Date/Time-Related Software Problem
2400
2400
Use of Device Problem
2345
2345
Detachment of Device or Device Component
2342
2342
Leak/Splash
2296
2296
Failure to Cycle
2079
2079
Circuit Failure
2013
2013
Visual Prompts will not Clear
1915
1915
Poor Quality Image
1882
1882
Unexpected Therapeutic Results
1846
1846
Insufficient Information
1802
1802
Partial Blockage
1650
1650
Inappropriate or Unexpected Reset
1482
1482
Excess Flow or Over-Infusion
1423
1423
Premature Discharge of Battery
1146
1146
Device Operates Differently Than Expected
1047
2635
Loose or Intermittent Connection
944
944
Wireless Communication Problem
919
919
Computer Software Problem
810
810
Calibration Problem
780
780
Electrical /Electronic Property Problem
764
764
Component Missing
758
758
Fitting Problem
755
755
Loss of Data
675
675
Incorrect Or Inadequate Test Results
581
581
Failure of Device to Self-Test
551
551
Material Separation
499
499
Mechanical Jam
488
488
Device Inoperable
449
449
Fracture
430
430
Unintended Movement
416
416
Detachment Of Device Component
411
411
Bent
388
388
Failure to Deliver
386
386
Material Twisted/Bent
378
378
Temperature Problem
360
360
High Test Results
329
329
Device Markings/Labelling Problem
328
328
Human-Device Interface Problem
321
321
Failure to Power Up
247
247
Overheating of Device
241
241
Failure to Auto Stop
238
238
Loss of Power
234
234
Intermittent Communication Failure
209
209
Environmental Compatibility Problem
173
173
Improper Flow or Infusion
169
169
Material Frayed
169
169
Nonstandard Device
149
149
Moisture Damage
141
141
Noise, Audible
128
128
Material Deformation
120
120
Manufacturing, Packaging or Shipping Problem
115
115
Component Falling
113
113
Activation Problem
111
111
Air Leak
110
110
Difficult to Remove
109
109
Sticking
108
108
Material Protrusion/Extrusion
107
107
Low Battery
106
106
Scratched Material
101
101
Fluid/Blood Leak
97
97
False Reading From Device Non-Compliance
93
93
Disconnection
88
88
Unexpected Shutdown
80
80
Device Fell
80
80
Low Test Results
80
80
Low Readings
79
79
Difficult to Insert
78
78
Device Slipped
77
77
Failure to Read Input Signal
73
73
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
129934
138015
No Clinical Signs, Symptoms or Conditions
84521
84521
Hyperglycemia
43594
43594
No Known Impact Or Consequence To Patient
26160
26160
Hypoglycemia
15272
15272
Insufficient Information
13822
13822
Diabetic Ketoacidosis
4122
4122
Nausea
1052
1052
Vomiting
993
993
Blood Loss
634
634
Loss of consciousness
575
575
Death
441
441
Abdominal Pain
355
355
Dyspnea
286
286
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
231
231
Headache
230
230
Pain
221
221
Coma
212
212
Fatigue
200
200
No Patient Involvement
182
182
Confusion/ Disorientation
180
180
Foreign Body In Patient
163
163
Unspecified Tissue Injury
149
149
Polydipsia
146
146
Dizziness
139
139
Seizures
137
137
Complaint, Ill-Defined
121
121
Unspecified Infection
102
102
Dehydration
100
100
Skin Irritation
99
99
Bruise/Contusion
98
98
Shaking/Tremors
79
79
Chest Pain
75
75
Fall
74
74
Blurred Vision
69
69
Diarrhea
51
51
Myocardial Infarction
48
48
Renal Failure
48
48
Pneumonia
48
48
Sweating
48
48
Cardiac Arrest
47
47
Discomfort
46
46
Skin Inflammation
43
43
Rash
43
43
Malaise
40
40
Urinary Frequency
39
39
Weakness
38
38
Swelling
36
36
Bone Fracture(s)
35
35
Muscle Weakness
34
34
Itching Sensation
34
34
Convulsion/Seizure
33
33
High Blood Pressure/ Hypertension
31
31
Stroke/CVA
30
30
Anxiety
27
27
Reaction, Injection Site
25
25
Lethargy
25
25
Cancer
23
23
Inflammation
23
23
Fever
22
22
Needle Stick/Puncture
21
21
Heart Failure/Congestive Heart Failure
20
20
Urinary Tract Infection
20
20
Urinary Retention
19
19
Hematoma
19
19
Convulsion, Clonic
18
18
Visual Impairment
16
16
Tachycardia
16
16
Dysphagia/ Odynophagia
16
16
Scar Tissue
15
15
No Code Available
14
14
Fainting
13
13
Head Injury
12
12
Hemorrhage/Bleeding
12
12
Irritation
12
12
Diaphoresis
12
12
Unspecified Heart Problem
12
12
Shock, Insulin
11
11
Hypersensitivity/Allergic reaction
11
11
Erythema
11
11
Memory Loss/Impairment
10
10
Sepsis
10
10
Abdominal Cramps
10
10
Numbness
9
9
Syncope/Fainting
9
9
Hyperemia
9
9
Congestive Heart Failure
9
9
Purulent Discharge
8
8
Foreign Body Reaction
8
8
Scarring
8
8
Brain Injury
8
8
Cramp(s) /Muscle Spasm(s)
8
8
Dysuria
8
8
Laceration(s)
7
7
Bronchitis
7
7
Low Blood Pressure/ Hypotension
7
7
Burn(s)
7
7
Abrasion
7
7
Liver Damage/Dysfunction
6
6
Neuropathy
6
6
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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