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
1.  K211575  Omnipod® Insulin Management System, Omnipod DASH® ...
2.  K223372  Omnipod GO Insulin Delivery Device
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	3322	3322

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	26192	26192
Material Twisted/Bent	25659	25752
Loss of or Failure to Bond	19915	19915
Failure to Fire	10504	10504
Insufficient Information	10436	10436
Activation, Positioning or Separation Problem	6804	6911
Fluid/Blood Leak	6786	6786
Mechanical Problem	6675	6675
Difficult to Insert	6664	6664
Premature Activation	6149	6149
Battery Problem	3843	3843
Retraction Problem	3154	3261
Obstruction of Flow	3136	3136
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	1448	1448
Failure to Cycle	1414	1414
Fail-Safe Did Not Operate	1380	1380
Charging Problem	1292	1292
Break	1212	1212
Failure to Sense	1150	1150
Display Difficult to Read	846	846
Difficult or Delayed Activation	838	838
Key or Button Unresponsive/not Working	795	795
No Display/Image	731	731
Overheating of Device	687	687
Premature Separation	681	681
Display or Visual Feedback Problem	600	600
Detachment of Device or Device Component	588	588
Device Sensing Problem	567	567
Material Integrity Problem	539	539
Power Problem	519	519
Inappropriate or Unexpected Reset	471	471
Priming Problem	432	432
False Alarm	431	431
Physical Resistance/Sticking	337	337
Device Displays Incorrect Message	334	334
Loss of Data	333	333
Computer Software Problem	329	329
Appropriate Term/Code Not Available	312	312
Loose or Intermittent Connection	303	303
Filling Problem	290	290
Device Alarm System	274	274
Material Split, Cut or Torn	268	268
Date/Time-Related Software Problem	254	254
Thermal Decomposition of Device	243	243

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	69798	69798
No Clinical Signs, Symptoms or Conditions	42060	42060
No Consequences Or Impact To Patient	7714	7714
No Information	6229	6336
No Known Impact Or Consequence To Patient	3109	3109
Diabetic Ketoacidosis	2777	2777
Insufficient Information	2468	2468
Pain	2061	2061
Hypoglycemia	2042	2042
Skin Inflammation/ Irritation	1961	1961
Vomiting	1779	1779
Skin Infection	1176	1176
Nausea	1055	1055
Loss of consciousness	667	667
Purulent Discharge	608	608
Hemorrhage/Bleeding	471	471
Swelling/ Edema	469	469
Unspecified Infection	424	424
Dehydration	421	421
Itching Sensation	359	359
Bruise/Contusion	334	334
Skin Irritation	324	324
Headache	288	288
Dizziness	286	286
Abscess	250	250
Erythema	244	244
Cellulitis	207	207
Rash	201	201
Fatigue	163	163
Hypersensitivity/Allergic reaction	154	154
Scar Tissue	152	152
Irritation	133	133
Convulsion/Seizure	126	126
Fever	120	120
Chest Pain	115	115
Bacterial Infection	112	112
Coma	107	107
Burning Sensation	106	106
Abdominal Cramps	101	101
Diarrhea	87	87
Cognitive Changes	71	71
Urinary Frequency	67	67
Urticaria	61	61
Blurred Vision	52	52
Swelling	51	51
Polydipsia	49	49
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