TPLC - Total Product Life Cycle

• 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
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC MINIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
MODULAR MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
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
Material Twisted/Bent	29992	35292
Unintended Movement	26936	26936
Loss of or Failure to Bond	18809	19988
Insufficient Information	12670	16419
Failure to Fire	9663	9663
Activation, Positioning or Separation Problem	7887	13216
Difficult to Insert	7020	7020
Mechanical Problem	6931	6931
Fluid/Blood Leak	6788	6788
Premature Activation	5892	5892
Battery Problem	4518	4518
Positioning Failure	4098	9412
Pumping Stopped	3879	3879
Obstruction of Flow	3794	3794
Retraction Problem	3337	8651
Device Difficult to Program or Calibrate	3091	3091
Inadequate User Interface	3023	3023
Incorrect Measurement	2727	2728
Inaccurate Delivery	2424	2445
Charging Problem	2120	2120
Adverse Event Without Identified Device or Use Problem	2043	2043
Fail-Safe Did Not Operate	1684	1684
Failure to Sense	1668	1676
Failure to Cycle	1530	1530
Break	1174	1174
Display Difficult to Read	1031	1031
Device Displays Incorrect Message	947	1194
No Display/Image	920	1015
Device Sensing Problem	839	839
False Alarm	788	788
Detachment of Device or Device Component	755	755
Difficult or Delayed Activation	733	733
Appropriate Term/Code Not Available	732	732
Premature Separation	728	728
Overheating of Device	683	683
Structural Problem	660	1552
Physical Resistance/Sticking	571	571
Key or Button Unresponsive/not Working	568	568
Filling Problem	563	563
Inappropriate or Unexpected Reset	525	525
Power Problem	523	523
Display or Visual Feedback Problem	479	479
Material Integrity Problem	468	468
Image Display Error/Artifact	422	824
Crack	421	421
Priming Problem	408	408
Loose or Intermittent Connection	395	395
Date/Time-Related Software Problem	364	367
Device Alarm System	350	350
Use of Device Problem	349	349

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	78501	78501
No Clinical Signs, Symptoms or Conditions	38109	38109
No Consequences Or Impact To Patient	17486	19624
No Information	8135	13449
No Known Impact Or Consequence To Patient	5715	5715
Diabetic Ketoacidosis	3525	3525
Hypoglycemia	2622	2622
Insufficient Information	2463	2463
Pain	2198	2198
Vomiting	2103	2103
Skin Inflammation/ Irritation	1861	1861
Nausea	1209	1209
Skin Infection	1110	1110
Unspecified Infection	835	835
Purulent Discharge	724	724
Loss of consciousness	703	703
Dehydration	540	540
Irritation	442	442
Skin Irritation	442	442
Itching Sensation	434	434
Swelling/ Edema	425	425
Hemorrhage/Bleeding	369	369
Bruise/Contusion	353	353
Headache	318	318
Dizziness	289	289
Abscess	288	288
Cellulitis	262	262
Rash	260	260
Erythema	164	164
Fatigue	154	154
Hypersensitivity/Allergic reaction	153	153
Scar Tissue	143	143
Bacterial Infection	140	140
Chest Pain	132	132
Fever	129	129
Convulsion/Seizure	121	121
Swelling	120	120
Burning Sensation	119	119
Coma	113	113
Death	103	103
Diarrhea	97	97
Abdominal Cramps	96	96
No Patient Involvement	88	88
Abdominal Pain	80	80
Cognitive Changes	68	68
Reaction	65	65
Seizures	64	64
Urinary Frequency	64	64
Blurred Vision	57	57
Urinary Tract Infection	48	48

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