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TPLC
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Device
pump, infusion, insulin
Product Code
LZG
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
INSULET CORPORATION
SUBSTANTIALLY EQUIVALENT
5
MEDTRONIC MINIMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
32651
48060
2019
29027
36372
2020
32586
32693
2021
31523
31523
2022
28229
28229
2023
20559
20559
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Twisted/Bent
30679
38765
Unintended Movement
25775
29148
Loss of or Failure to Bond
15455
16634
Insufficient Information
13663
18592
Activation, Positioning or Separation Problem
7882
18190
Failure to Fire
7818
7818
Pumping Stopped
7585
7585
Mechanical Problem
7341
7341
Difficult to Insert
6803
6803
Fluid/Blood Leak
6397
6397
Premature Activation
5457
5457
Battery Problem
4763
4763
Obstruction of Flow
4508
4508
Positioning Failure
4481
14774
Incorrect Measurement
4473
4489
Device Difficult to Program or Calibrate
3657
3657
Charging Problem
3574
3574
Inadequate User Interface
3395
3395
Adverse Event Without Identified Device or Use Problem
3284
3284
Device Displays Incorrect Message
3228
4444
Retraction Problem
3211
13567
Inaccurate Delivery
2771
2937
Failure to Sense
2140
2209
Fail-Safe Did Not Operate
1705
1705
False Alarm
1606
1606
Bent
1583
3776
Failure to Cycle
1511
1511
Device Sensing Problem
1338
1338
Failure to Prime
1241
1396
No Display/Image
1196
2081
Filling Problem
1158
1158
Display Difficult to Read
1046
1046
Break
946
946
Device Operates Differently Than Expected
943
943
Use of Device Problem
889
889
Structural Problem
836
5741
Crack
826
826
Detachment of Device or Device Component
824
824
Leak/Splash
798
8645
Inappropriate or Unexpected Reset
758
758
Appropriate Term/Code Not Available
713
713
Visual Prompts will not Clear
703
703
Premature Separation
695
695
Overheating of Device
674
674
Physical Resistance/Sticking
651
651
Occlusion Within Device
566
566
Loose or Intermittent Connection
565
565
Difficult or Delayed Activation
543
543
Image Display Error/Artifact
499
2988
Date/Time-Related Software Problem
498
616
Insufficient Flow or Under Infusion
475
475
Power Problem
467
467
Partial Blockage
456
489
Data Problem
434
434
Device Alarm System
418
418
Display or Visual Feedback Problem
396
396
Fail-Safe Problem
389
1584
Poor Quality Image
382
382
Material Integrity Problem
374
374
Premature Discharge of Battery
372
1197
Patient Device Interaction Problem
358
358
Moisture Damage
324
1891
Loss of Data
320
320
Computer Software Problem
304
304
Electrical /Electronic Property Problem
302
1956
Priming Problem
295
295
Fitting Problem
291
291
Material Split, Cut or Torn
288
288
Failure To Adhere Or Bond
283
283
Pumping Problem
271
388
Device Inoperable
216
216
Failure to Read Input Signal
211
1179
Thermal Decomposition of Device
201
201
Failure to Power Up
195
195
Wireless Communication Problem
190
190
Communication or Transmission Problem
179
240
Excess Flow or Over-Infusion
172
172
Temperature Problem
162
310
No Apparent Adverse Event
161
161
Intermittent Communication Failure
149
149
Device Issue
125
125
Material Deformation
124
124
Connection Problem
123
123
Incorrect, Inadequate or Imprecise Result or Readings
116
116
Physical Resistance
102
102
Failure to Reset
81
81
Unable to Obtain Readings
69
69
Moisture or Humidity Problem
69
69
Improper Flow or Infusion
65
65
Activation Problem
64
64
Material Separation
61
61
Defective Alarm
59
235
Reset Problem
57
57
Detachment Of Device Component
53
53
Failure to Deliver
47
47
Material Protrusion/Extrusion
46
46
Component Falling
43
43
Scratched Material
38
38
Failure of Device to Self-Test
37
37
Key or Button Unresponsive/not Working
36
36
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hyperglycemia
82382
82382
No Consequences Or Impact To Patient
34428
46959
No Clinical Signs, Symptoms or Conditions
31187
31187
No Known Impact Or Consequence To Patient
8482
8482
No Information
8228
18521
Diabetic Ketoacidosis
4398
4398
Hypoglycemia
3434
3434
Insufficient Information
2452
2452
Vomiting
2339
2339
Pain
2122
2122
Skin Inflammation/ Irritation
1624
1624
Nausea
1366
1366
Unspecified Infection
1101
1101
Skin Infection
954
954
Purulent Discharge
726
726
Loss of consciousness
720
720
Skin Irritation
687
687
Dehydration
660
660
Irritation
553
553
Itching Sensation
422
422
Bruise/Contusion
351
351
Headache
337
337
Swelling/ Edema
330
330
Dizziness
301
301
Abscess
294
294
Cellulitis
280
280
Rash
271
271
No Patient Involvement
234
234
Chest Pain
163
163
Hemorrhage/Bleeding
162
162
Death
161
161
Swelling
161
161
Bacterial Infection
157
157
Hypersensitivity/Allergic reaction
143
143
Fever
142
142
Scar Tissue
130
130
Fatigue
128
128
Coma
125
125
Abdominal Pain
124
124
Polydipsia
124
124
Urinary Frequency
119
119
Seizures
110
110
Convulsion/Seizure
106
106
Burning Sensation
103
103
Lethargy
96
96
Confusion/ Disorientation
95
95
Diarrhea
92
92
Abdominal Cramps
91
91
Reaction
82
82
Blurred Vision
79
79
No Code Available
77
77
Cognitive Changes
76
76
Skin Inflammation
55
55
Erythema
54
54
Renal Failure
48
48
Urinary Tract Infection
45
45
Pneumonia
43
43
Fall
42
42
Weakness
41
41
Blood Loss
40
40
Ambulation Difficulties
34
34
Sweating
33
33
Burn(s)
33
33
Dyspnea
30
30
Fainting
28
28
Anxiety
28
28
Contact Dermatitis
27
27
Chills
26
26
Numbness
26
26
Heart Failure
25
25
Cardiac Arrest
24
24
Hematoma
23
23
Myocardial Infarction
23
23
High Blood Pressure/ Hypertension
22
22
Neuropathy
20
20
Discomfort
20
20
Urticaria
19
19
Virus
18
18
Stroke/CVA
18
18
Extreme Exhaustion
18
18
Sepsis
17
17
Skin Discoloration
17
17
Inflammation
16
16
Respiratory Failure
14
14
Chemical Exposure
13
13
Fluid Discharge
12
12
Shaking/Tremors
12
12
Post Traumatic Wound Infection
12
12
Hypoglycemic Shock
12
12
Eczema
11
11
Cyst(s)
11
11
Visual Disturbances
11
11
Malaise
10
10
Bone Fracture(s)
10
10
Caustic/Chemical Burns
10
10
Low Blood Pressure/ Hypotension
9
9
Cardiopulmonary Arrest
9
9
Dysphasia
9
9
Septic Shock
9
9
Staphylococcus Aureus
8
8
Recalls
Manufacturer
Recall Class
Date Posted
1
Insulet Corporation
I
Nov-15-2022
2
Insulet Corporation
II
Mar-10-2021
3
Insulet Corporation
II
May-29-2020
4
Insulet Corporation
II
Mar-20-2020
5
Insulet Corporation
II
Nov-07-2019
6
Medtronic Inc.
I
Nov-04-2019
7
Medtronic MiniMed
II
Mar-26-2020
8
Roche Diabetes Care, Inc.
II
Aug-26-2021
9
Valeritas, Incorporated
II
Oct-26-2019
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