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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
4
MEDTRONIC MINIMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
32649
48058
2019
29027
36372
2020
32586
32693
2021
31526
31526
2022
28246
28246
2023
4280
4280
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Twisted/Bent
28407
36493
Unintended Movement
20749
24122
Insufficient Information
12548
17477
Loss of or Failure to Bond
11045
12224
Pumping Stopped
7512
7512
Activation, Positioning or Separation Problem
7378
17686
Mechanical Problem
6364
6364
Failure to Fire
6338
6338
Difficult to Insert
5997
5997
Fluid/Blood Leak
5404
5404
Premature Activation
4782
4782
Positioning Failure
4481
14774
Incorrect Measurement
4405
4421
Obstruction of Flow
4285
4285
Battery Problem
4259
4259
Charging Problem
3540
3540
Device Difficult to Program or Calibrate
3428
3428
Inadequate User Interface
3244
3244
Device Displays Incorrect Message
3228
4444
Adverse Event Without Identified Device or Use Problem
3189
3189
Retraction Problem
2895
13251
Inaccurate Delivery
2545
2711
Failure to Sense
2046
2115
False Alarm
1601
1601
Bent
1583
3776
Fail-Safe Did Not Operate
1510
1510
Device Sensing Problem
1291
1291
Failure to Cycle
1245
1245
Failure to Prime
1241
1396
Filling Problem
1155
1155
No Display/Image
1076
1961
Device Operates Differently Than Expected
942
942
Display Difficult to Read
925
925
Use of Device Problem
860
860
Break
853
853
Structural Problem
836
5741
Crack
815
815
Leak/Splash
795
8642
Detachment of Device or Device Component
746
746
Inappropriate or Unexpected Reset
691
691
Visual Prompts will not Clear
683
683
Physical Resistance/Sticking
651
651
Appropriate Term/Code Not Available
645
645
Premature Separation
625
625
Occlusion Within Device
566
566
Loose or Intermittent Connection
550
550
Image Display Error/Artifact
499
2988
Date/Time-Related Software Problem
475
593
Overheating of Device
471
471
Insufficient Flow or Under Infusion
466
466
Partial Blockage
456
489
Data Problem
433
433
Difficult or Delayed Activation
394
394
Fail-Safe Problem
389
1584
Device Alarm System
388
388
Power Problem
381
381
Poor Quality Image
372
372
Patient Device Interaction Problem
356
356
Premature Discharge of Battery
347
1172
Moisture Damage
324
1891
Electrical /Electronic Property Problem
300
1954
Display or Visual Feedback Problem
298
298
Fitting Problem
284
284
Failure To Adhere Or Bond
283
283
Pumping Problem
271
388
Material Split, Cut or Torn
268
268
Material Integrity Problem
254
254
Loss of Data
248
248
Computer Software Problem
243
243
Priming Problem
233
233
Device Inoperable
216
216
Failure to Read Input Signal
211
1179
Wireless Communication Problem
168
168
Failure to Power Up
163
163
No Apparent Adverse Event
161
161
Temperature Problem
159
307
Excess Flow or Over-Infusion
154
154
Communication or Transmission Problem
153
214
Intermittent Communication Failure
127
127
Device Issue
125
125
Material Deformation
123
123
Incorrect, Inadequate or Imprecise Result or Readings
113
113
Connection Problem
107
107
Physical Resistance
102
102
Thermal Decomposition of Device
85
85
Failure to Reset
81
81
Unable to Obtain Readings
69
69
Improper Flow or Infusion
64
64
Activation Problem
61
61
Material Separation
60
60
Moisture or Humidity Problem
59
59
Defective Alarm
58
234
Detachment Of Device Component
53
53
Reset Problem
47
47
Material Protrusion/Extrusion
46
46
Failure to Deliver
45
45
Component Falling
43
43
Scratched Material
38
38
Application Interface Becomes Non-Functional Or Program Exits Abnormally
32
32
Device Contamination with Chemical or Other Material
31
31
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hyperglycemia
73350
73350
No Consequences Or Impact To Patient
34428
46959
No Clinical Signs, Symptoms or Conditions
24622
24622
No Known Impact Or Consequence To Patient
8482
8482
No Information
8228
18521
Diabetic Ketoacidosis
4102
4102
Hypoglycemia
3208
3208
Insufficient Information
2416
2416
Vomiting
2162
2162
Pain
1825
1825
Skin Inflammation/ Irritation
1338
1338
Nausea
1256
1256
Unspecified Infection
1096
1096
Skin Infection
770
770
Skin Irritation
687
687
Purulent Discharge
639
639
Loss of consciousness
623
623
Dehydration
615
615
Irritation
553
553
Itching Sensation
356
356
Bruise/Contusion
311
311
Headache
301
301
Dizziness
265
265
Swelling/ Edema
263
263
Cellulitis
260
260
Abscess
256
256
Rash
236
236
No Patient Involvement
234
234
Swelling
161
161
Death
161
161
Chest Pain
151
151
Bacterial Infection
147
147
Hypersensitivity/Allergic reaction
134
134
Fever
125
125
Abdominal Pain
123
123
Urinary Frequency
115
115
Polydipsia
114
114
Coma
111
111
Scar Tissue
111
111
Seizures
110
110
Fatigue
110
110
Lethargy
93
93
Confusion/ Disorientation
92
92
Convulsion/Seizure
84
84
Diarrhea
83
83
Reaction
82
82
Burning Sensation
81
81
No Code Available
77
77
Blurred Vision
73
73
Abdominal Cramps
72
72
Cognitive Changes
66
66
Skin Inflammation
55
55
Renal Failure
46
46
Pneumonia
42
42
Weakness
41
41
Blood Loss
40
40
Urinary Tract Infection
38
38
Fall
38
38
Sweating
33
33
Ambulation Difficulties
33
33
Fainting
28
28
Burn(s)
28
28
Heart Failure
25
25
Hematoma
23
23
High Blood Pressure/ Hypertension
22
22
Cardiac Arrest
22
22
Chills
22
22
Contact Dermatitis
22
22
Anxiety
21
21
Numbness
20
20
Neuropathy
19
19
Virus
18
18
Myocardial Infarction
18
18
Sepsis
17
17
Skin Discoloration
17
17
Discomfort
17
17
Extreme Exhaustion
15
15
Dyspnea
15
15
Stroke/CVA
14
14
Respiratory Failure
13
13
Post Traumatic Wound Infection
12
12
Chemical Exposure
12
12
Cyst(s)
11
11
Caustic/Chemical Burns
10
10
Fluid Discharge
9
9
Hypoglycemic Shock
9
9
Cardiopulmonary Arrest
9
9
Hemorrhage/Bleeding
9
9
Inflammation
9
9
Bone Fracture(s)
8
8
Injury
8
8
Malaise
8
8
Depression
8
8
Staphylococcus Aureus
8
8
Visual Disturbances
8
8
Shaking/Tremors
8
8
Diaphoresis
7
7
Tachycardia
7
7
Septic Shock
7
7
Irritability
7
7
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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