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
	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	5099	5100

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	26009	26010
Loss of or Failure to Bond	21269	21269
Material Twisted/Bent	20520	20523
Failure to Fire	11366	11366
Insufficient Device Problem Information	8516	8520
Fluid/Blood Leak	7067	7069
Mechanical Problem	6889	6889
Premature Activation	5856	5856
Difficult to Insert	5802	5803
Activation, Positioning or Separation Problem	4620	4622
Obstruction of Flow	3992	3992
Battery Problem	2864	2864
Retraction Problem	2353	2353
Inadequate User Interface	1645	1645
Inaccurate Delivery	1548	1549
Failure to Cycle	1476	1476
Device Difficult to Program or Calibrate	1290	1290
Adverse Event Without Identified Device or Use Problem	1140	1140
Difficult or Delayed Activation	1127	1127
Fail-Safe Did Not Operate	1073	1073
Break	1013	1013
Pumping Stopped	980	986
Key or Button Unresponsive/not Working	972	972
Material Integrity Problem	853	853
Display or Visual Feedback Problem	812	812
Overheating of Device	741	741
No Display/Image	702	702
Incorrect Measurement	683	683
Display Difficult to Read	667	667
Failure to Sense	643	643
Detachment of Device or Device Component	577	577
Charging Problem	519	519
Power Problem	514	514
Priming Problem	488	488
Premature Separation	419	419
Inappropriate or Unexpected Reset	381	381
Computer Software Problem	341	341
Loss of Data	335	336
Material Split, Cut or Torn	312	312
Appropriate Device Problem Term/Code Not Available	304	304
Device Sensing Problem	263	263
Thermal Decomposition of Device	256	256
Failure of Device to Self-Test	244	244
Use of Device Problem	238	238
Premature Discharge of Battery	211	211
Device Alarm System	201	201
Fracture	197	197
Communication or Transmission Problem	191	192
False Alarm	171	171
No Visual Prompts/Feedback	170	170

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hyperglycemia	61653	61688
No Clinical Signs, Symptoms or Conditions	48826	48834
Insufficient Information	2407	2412
Elevated ketones/Diabetic Ketoacidosis	2225	2227
Skin Inflammation/ Irritation	2070	2085
Pain	1911	1911
Hypoglycemia	1611	1618
Vomiting	1532	1532
Skin Infection	1256	1257
Nausea	937	939
Hemorrhage/Blood Loss/Bleeding	745	745
Loss of consciousness	586	586
Swelling/ Edema	571	571
Purulent Discharge	550	550
Erythema	402	402
Dehydration	362	362
Itching Sensation	333	333
No Consequences Or Impact To Patient	295	295
Bruise/Contusion	293	293
Dizziness	293	293
Headache	283	283
Abscess	228	228
Fatigue	201	201
Rash	183	197
Cellulitis	168	168
Scar Tissue	166	166
Hypersensitivity/Allergic reaction	158	158
Convulsion/Seizure	128	128
Abdominal Cramps	118	119
Burning Sensation	106	106
Fever	106	106
Coma	98	98
Chest Pain	93	93
Diarrhea	92	92
Bacterial Infection	90	90
Cognitive Changes	90	90
No Known Impact Or Consequence To Patient	80	80
Urinary Frequency / Polyuria	76	77
Polydipsia	73	74
Unspecified Infection	73	73
Urticaria	70	70
Blurred Vision	55	55
Malaise	49	49
Discomfort	43	43
Contact Dermatitis	38	38
Urinary Tract Infection	38	38
Dyspnea	37	37
Chills	33	33
Burn(s)	33	33
Renal Failure	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