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
2021	31522	31547
2022	28225	28251
2023	21972	21983
2024	18228	18230
2025	12151	12151

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	25131	25132
Loss of or Failure to Bond	20484	20484
Material Twisted/Bent	20081	20084
Failure to Fire	11048	11048
Insufficient Information	8224	8228
Fluid/Blood Leak	6625	6629
Mechanical Problem	6343	6343
Premature Activation	5740	5740
Difficult to Insert	5581	5581
Activation, Positioning or Separation Problem	4228	4231
Obstruction of Flow	3212	3213
Battery Problem	2792	2792
Retraction Problem	2309	2309
Inadequate User Interface	1650	1650
Inaccurate Delivery	1554	1557
Failure to Cycle	1381	1381
Device Difficult to Program or Calibrate	1296	1296
Adverse Event Without Identified Device or Use Problem	1127	1127
Fail-Safe Did Not Operate	1074	1074
Difficult or Delayed Activation	1048	1048
Break	1011	1011
Pumping Stopped	984	990
Key or Button Unresponsive/not Working	858	858
Display or Visual Feedback Problem	718	718
Overheating of Device	717	717
Material Integrity Problem	689	689
Incorrect Measurement	686	686
No Display/Image	668	668
Display Difficult to Read	663	663
Failure to Sense	647	647
Detachment of Device or Device Component	552	552
Charging Problem	520	520
Power Problem	490	490
Priming Problem	459	459
Premature Separation	412	412
Inappropriate or Unexpected Reset	381	381
Computer Software Problem	326	326
Loss of Data	319	320
Appropriate Term/Code Not Available	304	304
Material Split, Cut or Torn	288	288
Device Sensing Problem	264	264
Thermal Decomposition of Device	251	251
Use of Device Problem	213	214
Device Alarm System	203	204
Failure of Device to Self-Test	203	203
Premature Discharge of Battery	200	206
Communication or Transmission Problem	183	184
False Alarm	173	173
Date/Time-Related Software Problem	165	165
Visual Prompts will not Clear	157	157

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	59680	59714
No Clinical Signs, Symptoms or Conditions	45810	45818
Insufficient Information	2402	2407
Diabetic Ketoacidosis	2153	2155
Skin Inflammation/ Irritation	2018	2033
Pain	1828	1828
Hypoglycemia	1583	1590
Vomiting	1466	1466
Skin Infection	1223	1224
Nausea	896	898
Hemorrhage/Bleeding	605	605
Loss of consciousness	567	567
Purulent Discharge	532	532
Swelling/ Edema	517	517
Dehydration	350	350
Erythema	328	328
Itching Sensation	313	313
No Consequences Or Impact To Patient	295	295
Dizziness	281	281
Bruise/Contusion	281	281
Headache	270	270
Abscess	218	218
Fatigue	182	182
Rash	177	191
Cellulitis	166	166
Scar Tissue	159	159
Hypersensitivity/Allergic reaction	149	149
Convulsion/Seizure	127	127
Abdominal Cramps	107	108
Burning Sensation	101	101
Fever	101	101
Coma	95	95
Chest Pain	91	91
Diarrhea	87	87
Bacterial Infection	85	85
Cognitive Changes	85	85
No Known Impact Or Consequence To Patient	80	80
Urinary Frequency	74	75
Urticaria	67	67
Unspecified Infection	66	66
Polydipsia	64	65
Blurred Vision	51	51
Discomfort	39	39
Contact Dermatitis	37	37
Urinary Tract Infection	37	37
Dyspnea	35	35
Burn(s)	33	33
Chills	31	31
Renal Failure	30	30
Fall	29	29

Recalls
Manufacturer		Recall Class	Date Posted
1	Insulet Corporation	I	Nov-15-2022
2	Insulet Corporation	II	Mar-10-2021
3	Medtronic MiniMed, Inc.	II	Mar-03-2025
4	Roche Diabetes Care, Inc.	II	Aug-26-2021