• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1
INSULET CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
ROCHE DIABETES CARE GMBH
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
TANDEM DIABETES CARE, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 4
TRIPLE JUMP ISRAEL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 30522 30522
2021 74701 74701
2022 129120 129120
2023 188016 188016
2024 17933 17933

Device Problems MDRs with this Device Problem Events in those MDRs
Pumping Stopped 108952 108952
Incorrect Measurement 48689 48689
Charging Problem 43738 43738
Obstruction of Flow 29890 29890
Adverse Event Without Identified Device or Use Problem 27441 27441
Failure to Sense 27439 27439
Communication or Transmission Problem 25917 25917
Battery Problem 22638 22638
Filling Problem 21557 21557
Crack 18356 18356
False Alarm 15776 15776
Mechanical Problem 14418 14418
Poor Quality Image 13166 13166
Device Sensing Problem 11200 11200
Unintended Movement 8655 8655
Physical Resistance/Sticking 8186 8186
Date/Time-Related Software Problem 7478 7478
Material Twisted/Bent 6983 6983
Inappropriate or Unexpected Reset 6952 6952
Data Problem 6568 6568
Loss of or Failure to Bond 6335 6335
Leak/Splash 5963 5963
Detachment of Device or Device Component 5924 5924
Loose or Intermittent Connection 4519 4519
Partial Blockage 3839 3839
Failure to Fire 3737 3737
Insufficient Information 3661 3661
Difficult to Insert 2631 2631
Fitting Problem 2628 2628
Break 2399 2399
Fluid/Blood Leak 2174 2174
Device Displays Incorrect Message 1766 1766
Improper Flow or Infusion 1536 1536
Premature Activation 1536 1536
Use of Device Problem 1410 1410
Activation, Positioning or Separation Problem 1331 1331
Failure to Power Up 1096 1096
Device Alarm System 846 846
Temperature Problem 771 771
Overheating of Device 678 678
Insufficient Flow or Under Infusion 636 636
Material Frayed 420 420
Excess Flow or Over-Infusion 418 418
Material Separation 391 391
Visual Prompts will not Clear 373 373
Retraction Problem 342 342
Thermal Decomposition of Device 313 313
Wireless Communication Problem 300 300
No Audible Alarm 278 278
Imprecision 261 261
Low Audible Alarm 250 250
Device Dislodged or Dislocated 224 224
Failure to Auto Stop 215 215
Difficult or Delayed Activation 166 166
Melted 111 111
Device Emits Odor 80 80
Disconnection 74 74
Device Contamination with Chemical or Other Material 72 72
Material Split, Cut or Torn 68 68
Intermittent Communication Failure 41 41
Smoking 41 41
Activation Problem 40 40
Sparking 35 35
Application Program Problem: Dose Calculation Error 32 32
Low impedance 31 31
Material Deformation 29 29
Material Discolored 26 26
No Flow 25 25
Unintended System Motion 23 23
Product Quality Problem 19 19
Measurement System Incompatibility 19 19
Device Fell 19 19
Problem with Software Installation 17 17
Solder Joint Fracture 17 17
Stretched 16 16
Fire 15 15
Burst Container or Vessel 15 15
Scratched Material 13 13
Corroded 10 10
Inaccurate Delivery 10 10
Application Program Problem 10 10
No Display/Image 9 9
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Inappropriate/Inadequate Shock/Stimulation 8 8
Failure to Deliver 7 7
Failure to Calibrate 7 7
Capturing Problem 7 7
Output Problem 7 7
Unexpected Shutdown 6 6
Expulsion 6 6
Computer Software Problem 6 6
Device Damaged by Another Device 5 5
Contamination /Decontamination Problem 5 5
Difficult to Remove 5 5
Unintended Electrical Shock 5 5
Patient Data Problem 5 5
Application Program Problem: Medication Error 5 5
Therapeutic or Diagnostic Output Failure 4 4
Power Problem 4 4
Material Integrity Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 352279 352279
Hyperglycemia 39602 39602
No Consequences Or Impact To Patient 24736 24736
Hypoglycemia 17717 17717
No Known Impact Or Consequence To Patient 4269 4269
Diabetic Ketoacidosis 3918 3918
Insufficient Information 1329 1329
Vomiting 1025 1025
Loss of consciousness 791 791
Nausea 671 671
Skin Inflammation/ Irritation 526 526
Pain 512 512
Fall 359 359
Convulsion/Seizure 310 310
Skin Infection 269 269
Erythema 259 259
Bruise/Contusion 244 244
Swelling/ Edema 233 233
Dehydration 221 221
Hemorrhage/Bleeding 217 217
Dizziness 184 184
Headache 163 163
Confusion/ Disorientation 160 160
Fatigue 107 107
Purulent Discharge 106 106
Itching Sensation 101 101
Chest Pain 86 86
Coma 86 86
Cellulitis 82 82
Scar Tissue 81 81
Urinary Retention 68 68
Bone Fracture(s) 62 62
Myocardial Infarction 59 59
Urinary Tract Infection 54 54
Shaking/Tremors 54 54
Rash 49 49
Syncope/Fainting 48 48
Unspecified Kidney or Urinary Problem 48 48
No Patient Involvement 47 47
Laceration(s) 46 46
Urinary Frequency 41 41
Head Injury 40 40
Diarrhea 39 39
Renal Failure 39 39
Burning Sensation 38 38
Fever 38 38
Blurred Vision 37 37
Cognitive Changes 36 36
Dyspnea 33 33
Urticaria 32 32
Memory Loss/Impairment 32 32
Abdominal Cramps 31 31
Stroke/CVA 30 30
Abscess 30 30
Seizures 27 27
Cardiac Arrest 26 26
Neuropathy 23 23
Burn(s) 22 22
Polydipsia 22 22
Numbness 22 22
Wound Dehiscence 21 21
Unspecified Infection 21 21
Pneumonia 20 20
Hypersensitivity/Allergic reaction 20 20
Chills 19 19
Diaphoresis 18 18
Malaise 17 17
Sepsis 17 17
Bacterial Infection 17 17
Anxiety 16 16
Visual Impairment 16 16
Unspecified Heart Problem 15 15
Abdominal Pain 14 14
Extreme Exhaustion 14 14
Brain Injury 13 13
Concussion 13 13
Weakness 12 12
Unspecified Eye / Vision Problem 12 12
Ambulation Difficulties 11 11
Abrasion 11 11
Lethargy 10 10
Injection Site Reaction 9 9
Hypothermia 9 9
Discomfort 9 9
Inflammation 9 9
Visual Disturbances 8 8
High Blood Pressure/ Hypertension 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Ulcer 8 8
Uremia 7 7
Respiratory Failure 7 7
Fluid Discharge 7 7
Speech Disorder 7 7
Hypoglycemic Shock 7 7
Hyperextension 7 7
Contact Dermatitis 7 7
Multiple Organ Failure 6 6
Cerebral Edema 6 6
Pallor 6 6
Thrombosis 6 6

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
-
-