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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 7 15 28 21 8 6 7 7 5

MDR Year MDR Reports MDR Events
2015 13 13
2016 63 63
2017 3605 3605
2018 30849 30849
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 116194 116194
Break 106327 106327
Adverse Event Without Identified Device or Use Problem 66679 66679
Patient Device Interaction Problem 62440 62440
No Display/Image 49925 49925
Appropriate Term/Code Not Available 47093 47093
Material Integrity Problem 42734 42734
Obstruction of Flow 42035 42037
Wireless Communication Problem 36897 36897
Mechanical Problem 32195 32195
Moisture or Humidity Problem 27113 27113
No Apparent Adverse Event 25755 25755
Device Difficult to Program or Calibrate 24191 24191
Battery Problem 22010 22010
Communication or Transmission Problem 19420 19420
Connection Problem 19238 19238
Circuit Failure 14167 14167
Device Alarm System 14086 14086
Computer Software Problem 13575 13575
Display or Visual Feedback Problem 13557 13557
Insufficient Flow or Under Infusion 11265 11265
Insufficient Information 9401 9401
Incorrect, Inadequate or Imprecise Result or Readings 7825 7825
Unexpected Therapeutic Results 7424 7424
Excess Flow or Over-Infusion 5572 5572
Calibration Problem 5517 5517
Electrical /Electronic Property Problem 5481 5481
Key or Button Unresponsive/not Working 5460 5460
Loss of Data 4922 4922
Visual Prompts will not Clear 4917 4917
Use of Device Problem 4765 4765
Physical Resistance/Sticking 4315 4315
Unintended Movement 3628 3628
Device Displays Incorrect Message 3303 3303
Priming Problem 2718 2718
Failure of Device to Self-Test 2519 2519
Mechanical Jam 2263 2263
Intermittent Loss of Power 1292 1292
Environmental Compatibility Problem 1280 1280
Device Markings/Labelling Problem 1094 1094
Fracture 1059 1059
Device Operates Differently Than Expected 1037 1037
Date/Time-Related Software Problem 979 979
Overheating of Device 758 758
Human-Device Interface Problem 741 741
Bent 552 552
Difficult to Remove 508 508
Manufacturing, Packaging or Shipping Problem 505 505
Intermittent Communication Failure 479 479
Incorrect Or Inadequate Test Results 346 346

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 336534 336536
No Consequences Or Impact To Patient 107303 107304
Hyperglycemia 91928 91928
Insufficient Information 46448 46448
Hypoglycemia 35249 35249
Diabetic Ketoacidosis 7533 7533
Nausea 3005 3005
Vomiting 2704 2704
Blood Loss 2070 2070
Loss of consciousness 1300 1300
Fatigue 1136 1136
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1114 1114
Headache 1078 1078
Abdominal Pain 1013 1013
Polydipsia 943 943
Confusion/ Disorientation 916 916
Malaise 857 857
Pain 789 789
Dyspnea 750 750
Hemorrhage/Bleeding 649 649
Shaking/Tremors 572 572
Dizziness 482 482
No Known Impact Or Consequence To Patient 420 420
Coma 355 355
Unspecified Tissue Injury 321 321
Diaphoresis 318 318
Bruise/Contusion 303 303
Skin Irritation 292 292
Discomfort 287 287
Dehydration 265 265
Foreign Body In Patient 259 259
Death 237 237
Muscle Weakness 236 236
Unspecified Infection 229 229
Blurred Vision 223 223
Convulsion, Clonic 204 204
Urinary Frequency 202 202
Complaint, Ill-Defined 193 193
Itching Sensation 181 181
Rash 174 174
Chest Pain 166 166
Anxiety 164 164
Seizures 151 151
Skin Inflammation/ Irritation 143 143
Hematoma 117 117
Cramp(s) /Muscle Spasm(s) 114 114
Sweating 113 113
Syncope/Fainting 105 105
Diarrhea 101 101
Skin Inflammation 95 95

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
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