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TPLC
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show TPLC since
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Device
pump, infusion, insulin
Product Code
LZG
Regulation Number
880.5725
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT DIABETES CARE INC.
SUBSTANTIALLY EQUIVALENT
1
ASANTE SOLUTIONS, INC
SUBSTANTIALLY EQUIVALENT
1
ASANTE SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
INSULET CORPORATION
SUBSTANTIALLY EQUIVALENT
11
M2 GROUP HOLDINGS, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDINGO LTD.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC MINIMED
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC MINIMED, INC.
SUBSTANTIALLY EQUIVALENT
1
MODULAR MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
ROCHE DIAGNOSTICS
SUBSTANTIALLY EQUIVALENT
1
TANDEM DIABETES CARE, INC.
SUBSTANTIALLY EQUIVALENT
7
VALERITAS, INC.
SUBSTANTIALLY EQUIVALENT
1
VALERITAS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
49177
49177
2015
69159
69159
2016
56614
64808
2017
44472
62462
2018
32651
48060
2019
29027
36372
2020
32586
32693
2021
31523
31523
2022
28229
28229
2023
22052
22052
2024
12692
12692
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
34453
38940
Material Twisted/Bent
32164
40250
Device Displays Incorrect Message
29324
32114
Pumping Stopped
20918
20918
Loss of or Failure to Bond
19299
20478
Insufficient Information
18580
23511
Crack
17973
17973
Device Operates Differently Than Expected
17473
18586
Mechanical Problem
16174
16202
Adverse Event Without Identified Device or Use Problem
15916
15916
Poor Quality Image
15170
17709
Break
13678
14464
Failure to Prime
12866
13574
No Display/Image
12473
14596
Incorrect Measurement
11692
11721
Battery Problem
11223
11431
Failure to Fire
9667
9667
Activation, Positioning or Separation Problem
9255
21550
Occlusion Within Device
9066
9113
Difficult to Insert
8036
8036
Fluid/Blood Leak
7660
7660
Inaccurate Delivery
7470
7860
Device Inoperable
7112
7722
Charging Problem
6883
6883
Premature Activation
5901
5901
Bent
5859
10039
Image Display Error/Artifact
5824
11835
Obstruction of Flow
5120
5120
Positioning Failure
5000
17280
Moisture Damage
4962
8557
Filling Problem
4522
4522
False Alarm
4013
4013
Structural Problem
3902
14865
Retraction Problem
3874
16297
Device Alarm System
3820
3837
Device Difficult to Program or Calibrate
3679
3679
Inadequate User Interface
3404
3404
Failure to Sense
3259
3442
Use of Device Problem
3187
3195
Fail-Safe Problem
2829
5156
Difficult or Delayed Activation
2816
2816
Leak/Splash
2728
10575
Visual Prompts will not Clear
2589
2589
Device Stops Intermittently
2235
2235
Moisture or Humidity Problem
2174
2372
Failure To Adhere Or Bond
1990
3977
Loss of Power
1957
1957
Inappropriate or Unexpected Reset
1940
1940
Fail-Safe Did Not Operate
1843
1843
Material Discolored
1793
1795
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hyperglycemia
138221
138270
No Known Impact Or Consequence To Patient
111454
119449
No Consequences Or Impact To Patient
93211
121877
No Clinical Signs, Symptoms or Conditions
38174
38174
Hypoglycemia
9735
9735
Diabetic Ketoacidosis
9433
9433
No Information
8944
21234
Vomiting
3870
3870
Nausea
3007
3007
Pain
2528
2528
Insufficient Information
2475
2475
Skin Inflammation/ Irritation
1861
1861
Unspecified Infection
1805
1805
Polydipsia
1607
1607
Dehydration
1395
1395
Skin Irritation
1362
1362
Loss of consciousness
1149
1149
Skin Infection
1110
1110
Urinary Frequency
1052
1052
No Patient Involvement
960
968
Dizziness
941
941
Purulent Discharge
866
866
Confusion/ Disorientation
750
750
Itching Sensation
660
660
Headache
659
659
Irritation
597
597
Abdominal Pain
582
582
Fatigue
458
458
Rash
454
454
Swelling/ Edema
425
425
Abscess
407
407
Blurred Vision
403
403
Bruise/Contusion
396
396
Hemorrhage/Bleeding
381
381
Cellulitis
366
366
Death
337
337
Lethargy
335
335
Chest Pain
325
325
Seizures
265
265
No Code Available
256
256
Cognitive Changes
247
247
Ambulation Difficulties
240
240
Coma
223
223
Swelling
192
192
Dyspnea
192
192
Bacterial Infection
192
192
Hypersensitivity/Allergic reaction
191
191
Erythema
174
174
Fever
172
172
Shaking/Tremors
163
163
Recalls
Manufacturer
Recall Class
Date Posted
1
Animas Corporation
II
Oct-24-2014
2
Animas Corporation
I
Apr-03-2013
3
Animas Corporation
III
Feb-17-2013
4
Animas Corporation
II
Oct-02-2012
5
Animas Corporation
II
Apr-06-2012
6
Animas Corporation
II
Aug-12-2011
7
Animas Corporation
II
May-10-2011
8
Animas Corporation
II
Sep-10-2010
9
Animas Corporation
III
May-08-2010
10
Animas Corporation
II
Mar-03-2009
11
Disetronic Medical Systems, Inc.
II
May-26-2009
12
Elcam Medical, Inc.
II
Sep-10-2015
13
Insulet Corporation
I
Nov-15-2022
14
Insulet Corporation
II
Mar-10-2021
15
Insulet Corporation
II
May-29-2020
16
Insulet Corporation
II
Mar-20-2020
17
Insulet Corporation
II
Nov-07-2019
18
Insulet Corporation
I
Dec-15-2015
19
Insulet Corporation
I
Sep-04-2015
20
Insulet Corporation
II
Nov-05-2013
21
Medtronic Inc.
I
Nov-04-2019
22
Medtronic MiniMed
II
Mar-26-2020
23
Medtronic MiniMed
III
Jun-25-2015
24
Medtronic MiniMed Inc.
III
Mar-02-2015
25
Roche Diabetes Care, Inc.
II
Aug-26-2021
26
Roche Diabetes Care, Inc.
II
Jun-09-2015
27
Roche Diagnostics Operations, Inc.
II
Oct-29-2014
28
Smiths Medical MD, Inc.
II
Apr-16-2009
29
Tandem Diabetes Care Inc
I
Feb-10-2014
30
Valeritas, Incorporated
II
Oct-26-2019
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