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TPLC - Total Product Life Cycle
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Device alternate controller enabled insulin infusion pump
Regulation Description Alternate controller enabled infusion pump.
Definition An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to be received, executed, and confirmed. ACE insulin pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of insulin delivery.
Product CodeQFG
Regulation Number 880.5730
Device Class 2


Premarket Reviews
ManufacturerDecision
BETA BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
DEKA RESEARCH & DEVELOPMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 3
EMBECTA MEDICAL I, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC MINIMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIABETES CARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 8
TRIPLE JUMP ISRAEL , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 74701 74719
2022 129119 129249
2023 188014 188299
2024 273180 273207
2025 328162 328239
2026 162345 162361

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 325077 325272
Charging Problem 89523 89564
Incorrect Measurement 81692 81712
Obstruction of Flow 72172 72202
Unintended Movement 71416 71430
Battery Problem 66128 66144
Loss of or Failure to Bond 64974 64987
Communication or Transmission Problem 55982 56050
Adverse Event Without Identified Device or Use Problem 52292 52311
Failure to Sense 40770 40801
Insufficient Information 34685 34694
Mechanical Problem 33319 33329
Material Twisted/Bent 30390 30398
Filling Problem 29978 29984
False Alarm 28297 28308
Crack 24319 24335
Device Sensing Problem 20275 20284
Failure to Charge 19676 19676
Poor Quality Image 19559 19569
Fluid/Blood Leak 16037 16039
Date/Time-Related Software Problem 15271 15274
Failure to Fire 15090 15090
Key or Button Unresponsive/not Working 13290 13292
Difficult to Insert 12675 12677
Detachment of Device or Device Component 12395 12398
Break 11324 11330
Inappropriate or Unexpected Reset 10220 10225
Loose or Intermittent Connection 8516 8518
Improper or Incorrect Procedure or Method 8275 8276
Data Problem 8164 8170
Premature Discharge of Battery 7949 7951
Leak/Splash 7747 7749
Fracture 6688 6692
Physical Resistance/Sticking 6653 6658
Activation, Positioning or Separation Problem 6593 6594
Fitting Problem 6144 6144
Use of Device Problem 5996 5998
Premature Activation 5918 5918
Partial Blockage 5402 5403
Intermittent Communication Failure 4646 4646
Failure to Power Up 3989 3992
Display or Visual Feedback Problem 3942 3946
Overheating of Device 3533 3535
Retraction Problem 1925 1925
Priming Problem 1849 1850
Improper Flow or Infusion 1673 1675
Failure to Infuse 1515 1515
Unexpected Shutdown 1420 1420
Air/Gas in Device 1416 1416
Excess Flow or Over-Infusion 1258 1263

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 903342 903810
Hyperglycemia 205761 205802
Hypoglycemia 42986 43008
Diabetic Ketoacidosis 10992 10996
Vomiting 4498 4500
Nausea 3584 3584
Erythema 3566 3566
Insufficient Information 3480 3493
Loss of consciousness 3289 3292
Pain 3200 3201
Hemorrhage/Bleeding 2904 2904
Skin Inflammation/ Irritation 2344 2345
Swelling/ Edema 2330 2330
Dizziness 2115 2117
No Consequences Or Impact To Patient 2062 2063
Skin Infection 1842 1842
Headache 1755 1755
Fatigue 1613 1614
Polydipsia 1418 1418
Confusion/ Disorientation 1320 1320
Shaking/Tremors 1319 1319
Convulsion/Seizure 1020 1022
Purulent Discharge 933 933
Malaise 928 928
Fall 794 796
Dehydration 775 775
Bruise/Contusion 759 761
Diaphoresis 743 744
Itching Sensation 664 665
Urinary Frequency 645 645
Dry Mouth 626 626
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 607 607
Anxiety 522 522
Lethargy 505 505
Cognitive Changes 476 476
Irritability 450 450
Hot Flashes/Flushes 383 383
Scar Tissue 381 381
Abscess 371 371
Cellulitis 356 356
Muscle Weakness 354 354
Dyspnea 328 328
No Known Impact Or Consequence To Patient 322 322
Blurred Vision 307 307
Chest Pain 295 295
Abdominal Cramps 264 265
Rash 264 264
Burning Sensation 253 253
Urticaria 251 251
Coma 217 217

Recalls
Manufacturer Recall Class Date Posted
1 Beta Bionics, Inc. II Apr-29-2026
2 Beta Bionics, Inc. II Apr-10-2026
3 Insulet Corporation I Apr-10-2026
4 Insulet Corporation I Jan-04-2024
5 Insulet Corporation II Sep-20-2023
6 Insulet Corporation II Dec-07-2022
7 Medtronic MiniMed, Inc. II Apr-02-2026
8 Medtronic MiniMed, Inc. II Mar-24-2026
9 Tandem Diabetes Care, Inc. II Mar-25-2026
10 Tandem Diabetes Care, Inc. I Nov-05-2025
11 Tandem Diabetes Care, Inc. II Oct-23-2025
12 Tandem Diabetes Care, Inc. II Sep-24-2025
13 Tandem Diabetes Care, Inc. I Aug-27-2025
14 Tandem Diabetes Care, Inc. I Apr-11-2025
15 Tandem Diabetes Care, Inc. I May-06-2024
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