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Device alternate controller enabled insulin 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 1
BETA BIONICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 3
EMBECTA MEDICAL I, LLC
  SUBSTANTIALLY EQUIVALENT 1
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIABETES CARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 6
  GRANTED 1
TRIPLE JUMP ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 30522 30522
2021 74701 74701
2022 129120 129120
2023 188017 188017
2024 179631 179632

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 156039 156039
Incorrect Measurement 59352 59352
Charging Problem 58633 58633
Battery Problem 49438 49438
Obstruction of Flow 36955 36955
Communication or Transmission Problem 34922 34922
Adverse Event Without Identified Device or Use Problem 34366 34366
Failure to Sense 33929 33929
Filling Problem 25915 25915
Crack 21605 21605
Unintended Movement 21174 21174
False Alarm 19368 19368
Mechanical Problem 18375 18375
Loss of or Failure to Bond 18152 18152
Poor Quality Image 16261 16261
Device Sensing Problem 15081 15081
Material Twisted/Bent 11241 11241
Date/Time-Related Software Problem 9710 9710
Detachment of Device or Device Component 8957 8957
Physical Resistance/Sticking 8192 8192
Inappropriate or Unexpected Reset 8141 8141
Data Problem 7488 7488
Leak/Splash 6640 6640
Insufficient Information 6046 6046
Failure to Fire 6040 6040
Loose or Intermittent Connection 5756 5756
Difficult to Insert 4492 4492
Partial Blockage 4401 4401
Fluid/Blood Leak 4093 4093
Break 3762 3762
Fitting Problem 3670 3670
Premature Activation 2403 2404
Activation, Positioning or Separation Problem 2187 2187
Failure to Power Up 1903 1903
Use of Device Problem 1778 1778
Device Displays Incorrect Message 1766 1766
Improper Flow or Infusion 1629 1629
Overheating of Device 1472 1472
Device Alarm System 986 986
Temperature Problem 772 772
Insufficient Flow or Under Infusion 742 742
Retraction Problem 520 520
Excess Flow or Over-Infusion 503 503
Material Separation 500 500
Material Frayed 443 443
Thermal Decomposition of Device 416 416
Visual Prompts will not Clear 415 415
No Audible Alarm 412 412
Difficult or Delayed Activation 404 404
Low Audible Alarm 376 376

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 479643 479644
Hyperglycemia 69280 69280
No Consequences Or Impact To Patient 24736 24736
Hypoglycemia 21777 21777
Diabetic Ketoacidosis 5488 5488
No Known Impact Or Consequence To Patient 4269 4269
Vomiting 1631 1631
Insufficient Information 1551 1551
Loss of consciousness 1244 1244
Nausea 1062 1062
Pain 872 872
Skin Inflammation/ Irritation 791 791
Erythema 704 704
Hemorrhage/Bleeding 616 616
Swelling/ Edema 504 504
Skin Infection 489 489
Fall 474 474
Convulsion/Seizure 430 430
Bruise/Contusion 362 362
Dehydration 323 323
Dizziness 307 307
Headache 256 256
Confusion/ Disorientation 222 222
Purulent Discharge 219 219
Fatigue 214 214
Itching Sensation 200 200
Scar Tissue 138 138
Cellulitis 118 118
Chest Pain 115 115
Coma 104 104
Rash 85 85
Urticaria 84 84
Urinary Frequency 78 78
Bone Fracture(s) 77 77
Urinary Tract Infection 77 77
Unspecified Kidney or Urinary Problem 76 76
Cognitive Changes 76 76
Urinary Retention 76 76
Abscess 71 71
Myocardial Infarction 71 71
Burning Sensation 67 67
Abdominal Cramps 65 65
Shaking/Tremors 65 65
Polydipsia 65 65
Dyspnea 62 62
Blurred Vision 60 60
Fever 58 58
Syncope/Fainting 58 58
Diarrhea 58 58
Laceration(s) 55 55

Recalls
Manufacturer Recall Class Date Posted
1 Insulet Corporation I Jan-04-2024
2 Insulet Corporation II Sep-20-2023
3 Insulet Corporation II Dec-07-2022
4 Tandem Diabetes Care, Inc. I May-06-2024
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