TPLC - Total Product Life Cycle

• Device: pump, infusion, insulin
• Regulation Description: Infusion pump.
• Product Code: LZG
• Regulation Number: 880.5725
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
INSULET CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC MINIMED
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC MINIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
MODULAR MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	32586	32693
2021	31523	31523
2022	28229	28229
2023	22052	22052
2024	18249	18249
2025	2113	2113

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	25827	25827
Material Twisted/Bent	25470	25563
Loss of or Failure to Bond	19595	19595
Failure to Fire	10379	10379
Insufficient Information	10374	10374
Activation, Positioning or Separation Problem	6744	6851
Fluid/Blood Leak	6689	6689
Difficult to Insert	6599	6599
Mechanical Problem	6596	6596
Premature Activation	6109	6109
Battery Problem	3819	3819
Retraction Problem	3151	3258
Obstruction of Flow	3045	3045
Positioning Failure	2975	3082
Inadequate User Interface	2298	2298
Device Difficult to Program or Calibrate	2275	2275
Pumping Stopped	2197	2197
Inaccurate Delivery	2053	2053
Incorrect Measurement	1670	1670
Adverse Event Without Identified Device or Use Problem	1440	1440
Failure to Cycle	1391	1391
Fail-Safe Did Not Operate	1380	1380
Charging Problem	1292	1292
Break	1212	1212
Failure to Sense	1150	1150
Display Difficult to Read	845	845
Difficult or Delayed Activation	824	824
Key or Button Unresponsive/not Working	769	769
No Display/Image	729	729
Overheating of Device	687	687
Premature Separation	679	679
Detachment of Device or Device Component	585	585
Display or Visual Feedback Problem	580	580
Device Sensing Problem	567	567
Material Integrity Problem	529	529
Power Problem	519	519
Inappropriate or Unexpected Reset	471	471
False Alarm	431	431
Priming Problem	428	428
Physical Resistance/Sticking	337	337
Device Displays Incorrect Message	334	334
Loss of Data	331	331
Computer Software Problem	327	327
Appropriate Term/Code Not Available	312	312
Loose or Intermittent Connection	303	303
Filling Problem	290	290
Device Alarm System	273	273
Material Split, Cut or Torn	266	266
Date/Time-Related Software Problem	252	252
Thermal Decomposition of Device	240	240

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	69131	69131
No Clinical Signs, Symptoms or Conditions	41549	41549
No Consequences Or Impact To Patient	7714	7714
No Information	6229	6336
No Known Impact Or Consequence To Patient	3109	3109
Diabetic Ketoacidosis	2765	2765
Insufficient Information	2468	2468
Pain	2051	2051
Hypoglycemia	2033	2033
Skin Inflammation/ Irritation	1941	1941
Vomiting	1771	1771
Skin Infection	1169	1169
Nausea	1047	1047
Loss of consciousness	662	662
Purulent Discharge	602	602
Hemorrhage/Bleeding	464	464
Swelling/ Edema	463	463
Unspecified Infection	424	424
Dehydration	420	420
Itching Sensation	352	352
Bruise/Contusion	334	334
Skin Irritation	324	324
Headache	286	286
Dizziness	282	282
Abscess	246	246
Erythema	230	230
Cellulitis	207	207
Rash	201	201
Fatigue	160	160
Hypersensitivity/Allergic reaction	154	154
Scar Tissue	147	147
Irritation	133	133
Convulsion/Seizure	125	125
Fever	117	117
Chest Pain	114	114
Bacterial Infection	112	112
Coma	107	107
Burning Sensation	106	106
Abdominal Cramps	101	101
Diarrhea	87	87
Cognitive Changes	71	71
Urinary Frequency	66	66
Urticaria	60	60
Blurred Vision	51	51
Swelling	51	51
Polydipsia	45	45
Renal Failure	41	41
Urinary Tract Infection	41	41
No Patient Involvement	39	39
Contact Dermatitis	37	37

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	Medtronic MiniMed	II	Mar-26-2020
6	Medtronic MiniMed, Inc.	II	Mar-03-2025
7	Roche Diabetes Care, Inc.	II	Aug-26-2021