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	17036	17036

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Twisted/Bent	30438	35738
Unintended Movement	28324	28324
Loss of or Failure to Bond	20092	21271
Insufficient Information	12909	16658
Failure to Fire	10073	10073
Activation, Positioning or Separation Problem	8028	13357
Mechanical Problem	7313	7313
Difficult to Insert	7188	7188
Fluid/Blood Leak	7022	7022
Premature Activation	6034	6034
Battery Problem	4602	4602
Positioning Failure	4098	9412
Obstruction of Flow	4008	4008
Pumping Stopped	3890	3890
Retraction Problem	3362	8676
Device Difficult to Program or Calibrate	3091	3091
Inadequate User Interface	3023	3023
Incorrect Measurement	2731	2732
Inaccurate Delivery	2513	2534
Charging Problem	2125	2125
Adverse Event Without Identified Device or Use Problem	2079	2079
Fail-Safe Did Not Operate	1684	1684
Failure to Sense	1673	1681
Failure to Cycle	1609	1609
Break	1215	1215
Display Difficult to Read	1033	1033
Device Displays Incorrect Message	947	1194
No Display/Image	946	1041
Device Sensing Problem	841	841
Detachment of Device or Device Component	794	794
False Alarm	789	789
Difficult or Delayed Activation	783	783
Appropriate Term/Code Not Available	762	762
Premature Separation	739	739
Overheating of Device	685	685
Key or Button Unresponsive/not Working	680	680
Structural Problem	660	1552
Physical Resistance/Sticking	571	571
Filling Problem	563	563
Display or Visual Feedback Problem	558	558
Power Problem	557	557
Inappropriate or Unexpected Reset	546	546
Material Integrity Problem	500	500
Priming Problem	450	450
Image Display Error/Artifact	422	824
Crack	421	421
Loose or Intermittent Connection	395	395
Use of Device Problem	374	374
Date/Time-Related Software Problem	370	373
Loss of Data	359	359

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	80780	80780
No Clinical Signs, Symptoms or Conditions	40052	40052
No Consequences Or Impact To Patient	17486	19624
No Information	8135	13449
No Known Impact Or Consequence To Patient	5715	5715
Diabetic Ketoacidosis	3589	3589
Hypoglycemia	2666	2666
Insufficient Information	2463	2463
Pain	2235	2235
Vomiting	2144	2144
Skin Inflammation/ Irritation	1899	1899
Nausea	1243	1243
Skin Infection	1141	1141
Unspecified Infection	839	839
Purulent Discharge	746	746
Loss of consciousness	724	724
Dehydration	545	545
Itching Sensation	443	443
Skin Irritation	442	442
Irritation	442	442
Swelling/ Edema	440	440
Hemorrhage/Bleeding	413	413
Bruise/Contusion	359	359
Headache	332	332
Dizziness	303	303
Abscess	294	294
Cellulitis	265	265
Rash	264	264
Erythema	198	198
Fatigue	172	172
Hypersensitivity/Allergic reaction	154	154
Scar Tissue	145	145
Bacterial Infection	142	142
Chest Pain	135	135
Fever	129	129
Burning Sensation	122	122
Convulsion/Seizure	122	122
Swelling	120	120
Coma	119	119
Death	103	103
Abdominal Cramps	101	101
Diarrhea	100	100
No Patient Involvement	88	88
Abdominal Pain	81	81
Cognitive Changes	71	71
Urinary Frequency	67	67
Reaction	65	65
Seizures	64	64
Blurred Vision	57	57
Polydipsia	53	53

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