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	32588	32705
2021	31522	31547
2022	28225	28240
2023	21972	21976
2024	18228	18228
2025	10405	10405

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	28073	28073
Material Twisted/Bent	26490	26583
Loss of or Failure to Bond	21614	21614
Failure to Fire	11032	11032
Insufficient Information	10854	10854
Mechanical Problem	7402	7402
Fluid/Blood Leak	7370	7373
Activation, Positioning or Separation Problem	7054	7162
Difficult to Insert	6942	6942
Premature Activation	6367	6367
Battery Problem	3932	3932
Obstruction of Flow	3743	3744
Retraction Problem	3166	3273
Positioning Failure	2975	3082
Inadequate User Interface	2298	2298
Device Difficult to Program or Calibrate	2275	2275
Pumping Stopped	2170	2170
Inaccurate Delivery	2057	2061
Incorrect Measurement	1657	1657
Failure to Cycle	1563	1563
Adverse Event Without Identified Device or Use Problem	1497	1497
Fail-Safe Did Not Operate	1380	1380
Charging Problem	1284	1284
Break	1214	1214
Failure to Sense	1133	1133
Difficult or Delayed Activation	1040	1040
Key or Button Unresponsive/not Working	902	902
Display Difficult to Read	851	851
No Display/Image	776	776
Display or Visual Feedback Problem	743	743
Overheating of Device	712	712
Premature Separation	690	690
Material Integrity Problem	664	664
Detachment of Device or Device Component	657	657
Device Sensing Problem	564	564
Power Problem	549	549
Priming Problem	484	484
Inappropriate or Unexpected Reset	470	470
False Alarm	431	431
Computer Software Problem	355	355
Loss of Data	346	346
Physical Resistance/Sticking	337	337
Device Displays Incorrect Message	335	337
Material Split, Cut or Torn	325	325
Appropriate Term/Code Not Available	316	316
Loose or Intermittent Connection	299	299
Filling Problem	289	289
Device Alarm System	283	285
Use of Device Problem	266	267
Thermal Decomposition of Device	252	252

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	73232	73256
No Clinical Signs, Symptoms or Conditions	45438	45440
No Consequences Or Impact To Patient	7714	7714
No Information	6229	6336
No Known Impact Or Consequence To Patient	3110	3112
Diabetic Ketoacidosis	2884	2884
Insufficient Information	2468	2477
Pain	2147	2147
Hypoglycemia	2104	2112
Skin Inflammation/ Irritation	2028	2042
Vomiting	1849	1849
Skin Infection	1225	1225
Nausea	1125	1125
Loss of consciousness	679	679
Purulent Discharge	631	631
Hemorrhage/Bleeding	566	566
Swelling/ Edema	514	514
Dehydration	438	438
Unspecified Infection	431	431
Itching Sensation	375	375
Bruise/Contusion	345	345
Skin Irritation	324	324
Dizziness	314	314
Headache	312	312
Erythema	312	312
Abscess	264	264
Cellulitis	209	209
Rash	206	220
Fatigue	192	192
Scar Tissue	158	158
Hypersensitivity/Allergic reaction	157	157
Irritation	133	133
Convulsion/Seizure	127	127
Fever	123	123
Chest Pain	122	122
Coma	114	114
Bacterial Infection	113	113
Burning Sensation	112	112
Abdominal Cramps	112	112
Diarrhea	92	92
Cognitive Changes	87	87
Urinary Frequency	77	77
Urticaria	67	67
Polydipsia	67	68
Blurred Vision	57	57
Swelling	51	51
Urinary Tract Infection	45	45
Renal Failure	41	41
Discomfort	40	40
No Patient Involvement	39	39

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