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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 3
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 1
ROCHE DIABETES CARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 9
TRIPLE JUMP ISRAEL , LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 30522 30523
2021 74701 74719
2022 129119 129249
2023 188014 188299
2024 273180 273207
2025 291151 291228

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 282901 283094
Charging Problem 86358 86399
Incorrect Measurement 78840 78860
Battery Problem 66713 66729
Obstruction of Flow 61575 61604
Unintended Movement 55768 55781
Loss of or Failure to Bond 50277 50289
Adverse Event Without Identified Device or Use Problem 50122 50139
Communication or Transmission Problem 47286 47351
Failure to Sense 42257 42288
Filling Problem 31773 31779
Mechanical Problem 29032 29042
False Alarm 26821 26832
Crack 25379 25395
Material Twisted/Bent 23751 23759
Device Sensing Problem 20640 20649
Poor Quality Image 20026 20036
Insufficient Information 15179 15184
Date/Time-Related Software Problem 14487 14490
Detachment of Device or Device Component 12619 12622
Failure to Fire 12483 12483
Fluid/Blood Leak 10902 10904
Inappropriate or Unexpected Reset 10302 10307
Difficult to Insert 9683 9684
Failure to Charge 9572 9572
Data Problem 8774 8780
Break 8568 8574
Physical Resistance/Sticking 8221 8226
Loose or Intermittent Connection 8045 8047
Leak/Splash 7829 7831
Partial Blockage 5848 5849
Key or Button Unresponsive/not Working 5808 5810
Fitting Problem 5436 5436
Use of Device Problem 5216 5217
Activation, Positioning or Separation Problem 4780 4780
Premature Activation 4685 4685
Premature Discharge of Battery 4257 4259
Failure to Power Up 3775 3778
Overheating of Device 3015 3017
Fracture 2106 2110
Device Displays Incorrect Message 1776 1777
Display or Visual Feedback Problem 1741 1742
Improper Flow or Infusion 1738 1740
Device Alarm System 1170 1171
Retraction Problem 1139 1139
Insufficient Flow or Under Infusion 1008 1008
Difficult or Delayed Activation 958 959
Excess Flow or Over-Infusion 932 937
No Display/Image 864 864
Improper or Incorrect Procedure or Method 831 831

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 770702 771159
Hyperglycemia 151478 151514
Hypoglycemia 32969 32988
No Consequences Or Impact To Patient 24736 24737
Diabetic Ketoacidosis 8994 8998
No Known Impact Or Consequence To Patient 4269 4270
Vomiting 3241 3242
Loss of consciousness 2677 2679
Nausea 2361 2361
Insufficient Information 2274 2287
Erythema 2203 2203
Pain 2089 2090
Hemorrhage/Bleeding 1805 1805
Skin Inflammation/ Irritation 1619 1620
Swelling/ Edema 1439 1439
Skin Infection 1249 1249
Dizziness 1095 1096
Headache 868 868
Fatigue 812 812
Convulsion/Seizure 795 796
Fall 680 681
Confusion/ Disorientation 639 639
Dehydration 619 619
Polydipsia 611 611
Bruise/Contusion 601 603
Purulent Discharge 598 598
Itching Sensation 435 436
Shaking/Tremors 420 420
Diaphoresis 328 329
Urinary Frequency 310 310
Cellulitis 283 283
Scar Tissue 256 256
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 238 238
Cognitive Changes 235 235
Malaise 234 234
Lethargy 233 233
Chest Pain 224 224
Abscess 218 218
Blurred Vision 214 214
Dyspnea 211 211
Abdominal Cramps 199 200
Coma 173 173
Anxiety 172 172
Rash 172 172
Urticaria 169 169
Burning Sensation 168 168
Dry Mouth 145 145
Fever 144 144
Diarrhea 135 135
Discomfort 123 123

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 Nov-05-2025
5 Tandem Diabetes Care, Inc. II Oct-23-2025
6 Tandem Diabetes Care, Inc. II Sep-24-2025
7 Tandem Diabetes Care, Inc. I Aug-27-2025
8 Tandem Diabetes Care, Inc. I Apr-11-2025
9 Tandem Diabetes Care, Inc. I May-06-2024
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