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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 2
ROCHE DIABETES CARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 6
TRIPLE JUMP ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 30522 30522
2021 74701 74701
2022 129119 129119
2023 188017 188017
2024 273182 273192

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 187194 187195
Charging Problem 67881 67882
Incorrect Measurement 65116 65118
Battery Problem 61710 61711
Obstruction of Flow 40515 40516
Communication or Transmission Problem 38569 38569
Adverse Event Without Identified Device or Use Problem 38436 38436
Failure to Sense 37828 37828
Unintended Movement 28792 28795
Filling Problem 28389 28390
Loss of or Failure to Bond 25243 25246
Crack 23246 23246
False Alarm 21267 21267
Mechanical Problem 20708 20708
Poor Quality Image 17848 17848
Device Sensing Problem 17299 17299
Material Twisted/Bent 13834 13834
Date/Time-Related Software Problem 11196 11196
Detachment of Device or Device Component 10779 10779
Inappropriate or Unexpected Reset 8697 8697
Physical Resistance/Sticking 8199 8199
Data Problem 7978 7978
Failure to Fire 7488 7488
Insufficient Information 7291 7291
Leak/Splash 6988 6988
Loose or Intermittent Connection 6421 6421
Difficult to Insert 5536 5536
Fluid/Blood Leak 5297 5297
Partial Blockage 4891 4891
Break 4621 4621
Fitting Problem 4310 4310
Premature Activation 2864 2865
Activation, Positioning or Separation Problem 2709 2709
Failure to Power Up 2375 2375
Use of Device Problem 2083 2083
Overheating of Device 1906 1906
Device Displays Incorrect Message 1766 1766
Improper Flow or Infusion 1664 1664
Device Alarm System 1051 1051
Insufficient Flow or Under Infusion 811 811
Temperature Problem 773 773
Retraction Problem 615 615
Material Separation 570 570
Excess Flow or Over-Infusion 559 559
Difficult or Delayed Activation 540 540
No Audible Alarm 493 493
Thermal Decomposition of Device 462 462
No Display/Image 447 447
Material Frayed 443 443
Visual Prompts will not Clear 430 430

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 553715 553722
Hyperglycemia 86273 86276
No Consequences Or Impact To Patient 24736 24736
Hypoglycemia 23894 23894
Diabetic Ketoacidosis 6310 6310
No Known Impact Or Consequence To Patient 4269 4269
Vomiting 1998 1998
Insufficient Information 1697 1697
Loss of consciousness 1549 1549
Nausea 1344 1344
Pain 1136 1136
Erythema 1013 1013
Skin Inflammation/ Irritation 956 956
Hemorrhage/Bleeding 890 890
Swelling/ Edema 689 689
Skin Infection 640 640
Convulsion/Seizure 515 515
Fall 513 513
Dizziness 434 434
Bruise/Contusion 415 415
Dehydration 394 394
Headache 362 362
Fatigue 293 293
Purulent Discharge 279 279
Confusion/ Disorientation 274 274
Itching Sensation 241 241
Scar Tissue 166 166
Cellulitis 149 149
Chest Pain 136 136
Polydipsia 125 125
Coma 120 120
Urinary Frequency 119 119
Cognitive Changes 110 110
Rash 100 100
Burning Sensation 100 100
Dyspnea 97 97
Abscess 97 97
Urticaria 97 97
Urinary Retention 91 91
Abdominal Cramps 90 90
Blurred Vision 87 87
Bone Fracture(s) 86 86
Urinary Tract Infection 85 85
Unspecified Kidney or Urinary Problem 82 82
Shaking/Tremors 77 77
Diarrhea 75 75
Myocardial Infarction 75 75
Fever 70 70
Syncope/Fainting 67 67
Malaise 63 63

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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