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	4243	4243

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	26437	26437
Material Twisted/Bent	25757	25850
Loss of or Failure to Bond	20123	20123
Failure to Fire	10591	10591
Insufficient Information	10495	10495
Activation, Positioning or Separation Problem	6850	6957
Fluid/Blood Leak	6843	6843
Mechanical Problem	6770	6770
Difficult to Insert	6707	6707
Premature Activation	6165	6165
Battery Problem	3860	3860
Obstruction of Flow	3229	3229
Retraction Problem	3155	3262
Positioning Failure	2975	3082
Inadequate User Interface	2298	2298
Device Difficult to Program or Calibrate	2275	2275
Pumping Stopped	2198	2198
Inaccurate Delivery	2055	2055
Incorrect Measurement	1670	1670
Adverse Event Without Identified Device or Use Problem	1454	1454
Failure to Cycle	1428	1428
Fail-Safe Did Not Operate	1380	1380
Charging Problem	1292	1292
Break	1212	1212
Failure to Sense	1151	1151
Difficult or Delayed Activation	852	852
Display Difficult to Read	849	849
Key or Button Unresponsive/not Working	817	817
No Display/Image	735	735
Overheating of Device	687	687
Premature Separation	681	681
Display or Visual Feedback Problem	615	615
Detachment of Device or Device Component	590	590
Device Sensing Problem	568	568
Material Integrity Problem	552	552
Power Problem	523	523
Inappropriate or Unexpected Reset	471	471
Priming Problem	436	436
False Alarm	431	431
Computer Software Problem	344	344
Loss of Data	339	339
Physical Resistance/Sticking	337	337
Device Displays Incorrect Message	334	334
Appropriate Term/Code Not Available	314	314
Loose or Intermittent Connection	303	303
Filling Problem	290	290
Device Alarm System	277	277
Material Split, Cut or Torn	268	268
Date/Time-Related Software Problem	254	254
Thermal Decomposition of Device	244	244

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	70246	70246
No Clinical Signs, Symptoms or Conditions	42501	42501
No Consequences Or Impact To Patient	7714	7714
No Information	6229	6336
No Known Impact Or Consequence To Patient	3109	3109
Diabetic Ketoacidosis	2797	2797
Insufficient Information	2468	2468
Pain	2070	2070
Hypoglycemia	2049	2049
Skin Inflammation/ Irritation	1974	1974
Vomiting	1785	1785
Skin Infection	1183	1183
Nausea	1059	1059
Loss of consciousness	670	670
Purulent Discharge	611	611
Hemorrhage/Bleeding	487	487
Swelling/ Edema	482	482
Unspecified Infection	425	425
Dehydration	423	423
Itching Sensation	360	360
Bruise/Contusion	335	335
Skin Irritation	324	324
Headache	291	291
Dizziness	287	287
Abscess	254	254
Erythema	253	253
Cellulitis	207	207
Rash	201	201
Fatigue	168	168
Hypersensitivity/Allergic reaction	154	154
Scar Tissue	154	154
Irritation	133	133
Convulsion/Seizure	126	126
Fever	120	120
Chest Pain	116	116
Bacterial Infection	112	112
Coma	110	110
Burning Sensation	106	106
Abdominal Cramps	104	104
Diarrhea	88	88
Cognitive Changes	79	79
Urinary Frequency	69	69
Urticaria	63	63
Polydipsia	52	52
Blurred Vision	52	52
Swelling	51	51
Urinary Tract Infection	43	43
Renal Failure	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