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
1.  K210714  Extended Reservoir
MEDTRONIC MINIMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
1.  K210714  Extended Reservoir
MODULAR MEDICAL
	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
2026	6199	6200

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	26257	26258
Loss of or Failure to Bond	21498	21498
Material Twisted/Bent	20623	20626
Failure to Fire	11434	11434
Insufficient Device Problem Information	8638	8642
Fluid/Blood Leak	7189	7191
Mechanical Problem	6969	6969
Premature Activation	5875	5875
Difficult to Insert	5857	5858
Activation, Positioning or Separation Problem	4655	4657
Obstruction of Flow	4113	4113
Battery Problem	2885	2885
Retraction Problem	2358	2358
Inadequate User Interface	1645	1645
Inaccurate Delivery	1548	1549
Failure to Cycle	1513	1513
Device Difficult to Program or Calibrate	1290	1290
Adverse Event Without Identified Device or Use Problem	1153	1153
Difficult or Delayed Activation	1142	1142
Fail-Safe Did Not Operate	1073	1073
Break	1015	1015
Key or Button Unresponsive/not Working	999	999
Pumping Stopped	980	986
Material Integrity Problem	907	907
Display or Visual Feedback Problem	841	841
Overheating of Device	754	754
No Display/Image	704	704
Incorrect Measurement	683	683
Display Difficult to Read	670	670
Failure to Sense	643	643
Detachment of Device or Device Component	581	581
Power Problem	522	522
Charging Problem	519	519
Priming Problem	496	496
Premature Separation	421	421
Inappropriate or Unexpected Reset	381	381
Computer Software Problem	346	346
Loss of Data	339	340
Material Split, Cut or Torn	324	324
Appropriate Device Problem Term/Code Not Available	304	304
Device Sensing Problem	266	266
Thermal Decomposition of Device	256	256
Failure of Device to Self-Test	254	254
Use of Device Problem	249	249
Fracture	232	232
Premature Discharge of Battery	214	214
Device Alarm System	202	202
Communication or Transmission Problem	193	194
No Visual Prompts/Feedback	192	192
False Alarm	171	171

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	62184	62219
No Clinical Signs, Symptoms or Conditions	49355	49363
Insufficient Information	2413	2418
Elevated ketones/Diabetic Ketoacidosis	2261	2263
Skin Inflammation/ Irritation	2090	2105
Pain	1923	1923
Hypoglycemia	1626	1633
Vomiting	1570	1570
Skin Infection	1261	1262
Nausea	941	943
Hemorrhage/Blood Loss/Bleeding	771	771
Loss of consciousness	588	588
Swelling/ Edema	578	578
Purulent Discharge	554	554
Erythema	418	418
Dehydration	367	367
Itching Sensation	337	337
Dizziness	322	322
No Consequences Or Impact To Patient	295	295
Bruise/Contusion	294	294
Headache	287	287
Abscess	230	230
Fatigue	205	205
Rash	185	199
Cellulitis	168	168
Scar Tissue	168	168
Hypersensitivity/Allergic reaction	158	158
Convulsion/Seizure	128	128
Abdominal Cramps	118	119
Fever	107	107
Burning Sensation	106	106
Coma	98	98
Chest Pain	93	93
Diarrhea	93	93
Cognitive Changes	92	92
Bacterial Infection	90	90
No Known Impact Or Consequence To Patient	80	80
Urinary Frequency / Polyuria	78	79
Polydipsia	75	76
Unspecified Infection	74	74
Urticaria	70	70
Blurred Vision	55	55
Malaise	54	54
Discomfort	44	44
Contact Dermatitis	39	39
Urinary Tract Infection	38	38
Dyspnea	37	37
Chills	33	33
Burn(s)	33	33
Fall	32	32

Recalls
Manufacturer		Recall Class	Date Posted
1	Insulet Corporation	I	Jun-30-2026
2	Insulet Corporation	I	Nov-15-2022
3	Insulet Corporation	II	Mar-10-2021
4	Medtronic MiniMed, Inc.	II	Apr-02-2026
5	Medtronic MiniMed, Inc.	II	Mar-03-2025
6	Roche Diabetes Care, Inc.	II	Aug-26-2021