Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 automated insulin dosing device system, single hormonal control
Definition An insulin-only automated insulin dosing system that achieves a target glucose level by automatically increasing or reducing insulin infusion from an insulin pump. Insulin adjustments are based upon specified thresholds of measured glucose levels.
Product CodeOZP
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
21 8 6 7 7 5

MDR Year MDR Reports MDR Events
2019 55504 55504
2020 74038 74038
2021 66221 66221
2022 154933 154933
2023 145192 145192
2024 83847 83849

Device Problems MDRs with this Device Problem Events in those MDRs
Power Problem 115597 115597
Break 105523 105523
Patient Device Interaction Problem 59902 59902
Adverse Event Without Identified Device or Use Problem 58396 58396
No Display/Image 47417 47417
Appropriate Term/Code Not Available 44593 44593
Material Integrity Problem 42600 42600
Obstruction of Flow 41741 41743
Wireless Communication Problem 36896 36896
Mechanical Problem 31761 31761
Moisture or Humidity Problem 26856 26856
Device Difficult to Program or Calibrate 23398 23398
Battery Problem 21845 21845
No Apparent Adverse Event 21819 21819
Communication or Transmission Problem 18990 18990
Connection Problem 18509 18509
Circuit Failure 13628 13628
Computer Software Problem 13245 13245
Display or Visual Feedback Problem 12977 12977
Device Alarm System 12678 12678
Insufficient Flow or Under Infusion 10821 10821
Insufficient Information 8022 8022
Unexpected Therapeutic Results 7165 7165
Incorrect, Inadequate or Imprecise Result or Readings 6750 6750
Key or Button Unresponsive/not Working 5460 5460
Electrical /Electronic Property Problem 5419 5419
Excess Flow or Over-Infusion 5241 5241
Calibration Problem 5072 5072
Loss of Data 4867 4867
Visual Prompts will not Clear 4790 4790
Use of Device Problem 4729 4729
Physical Resistance/Sticking 4314 4314
Unintended Movement 3593 3593
Priming Problem 2687 2687
Failure of Device to Self-Test 2467 2467
Mechanical Jam 2161 2161
Environmental Compatibility Problem 1278 1278
Intermittent Loss of Power 1249 1249
Device Markings/Labelling Problem 1076 1076
Fracture 1015 1015
Date/Time-Related Software Problem 948 948
Overheating of Device 728 728
Human-Device Interface Problem 607 607
Manufacturing, Packaging or Shipping Problem 490 490
Difficult to Remove 475 475
Intermittent Communication Failure 460 460
Material Twisted/Bent 295 295
Packaging Problem 206 206
Nonstandard Device 168 168
Inappropriate or Unexpected Reset 128 128

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 336533 336535
No Consequences Or Impact To Patient 92183 92183
Hyperglycemia 78250 78250
Insufficient Information 46448 46448
Hypoglycemia 28720 28720
Diabetic Ketoacidosis 7049 7049
Nausea 2945 2945
Vomiting 2652 2652
Blood Loss 1300 1300
Loss of consciousness 1254 1254
Fatigue 1133 1133
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1114 1114
Headache 1064 1064
Abdominal Pain 1000 1000
Polydipsia 934 934
Confusion/ Disorientation 915 915
Malaise 856 856
Dyspnea 743 743
Pain 654 654
Hemorrhage/Bleeding 648 648
Shaking/Tremors 570 570
Dizziness 476 476
Unspecified Tissue Injury 321 321
Diaphoresis 318 318
Coma 318 318
Bruise/Contusion 258 258
Dehydration 255 255
Discomfort 254 254
Muscle Weakness 236 236
Foreign Body In Patient 236 236
Blurred Vision 221 221
Convulsion, Clonic 203 203
Urinary Frequency 196 196
Unspecified Infection 193 193
Complaint, Ill-Defined 188 188
Death 177 177
Chest Pain 165 165
Anxiety 160 160
No Known Impact Or Consequence To Patient 160 160
Skin Inflammation/ Irritation 143 143
Seizures 131 131
Skin Irritation 125 125
Itching Sensation 118 118
Rash 114 114
Cramp(s) /Muscle Spasm(s) 114 114
Hematoma 114 114
Sweating 110 110
Syncope/Fainting 105 105
Diarrhea 100 100
Lethargy 85 85

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Dec-02-2020
2 Medtronic Inc. I Feb-07-2020
3 Medtronic Inc. II Jul-09-2019
4 Medtronic MiniMed II Nov-08-2022
5 Medtronic MiniMed II Jul-08-2022
6 Medtronic MiniMed II Mar-31-2022
7 Medtronic MiniMed, Inc. II Feb-07-2024
8 Medtronic Minimed II Jun-01-2021
-
-