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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pump, infusion, insulin, to be used with invasive glucose sensor
Definition The insulin pump is intended to be used as a component of an invasive glucose device. The pump is designed to pump fluid (insulin) into a patient in a controlled manner as an aid in the mangement of diabetes mellitus in persons requiring insulin. It is intended to accept and display data from the glucose sensor.
Product CodeOYC
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
13 9 2 0 0 0

MDR Year MDR Reports MDR Events
2017 132641 138181
2018 106240 119562
2019 99216 106695
2020 74592 74592
2021 50930 50930
2022 65511 65511

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 76427 86098
Patient Device Interaction Problem 70317 70317
Break 57609 57609
Power Problem 30700 30700
Mechanical Problem 24878 37797
No Display/Image 24820 24820
Device Difficult to Program or Calibrate 23349 34579
Adverse Event Without Identified Device or Use Problem 22671 22671
Structural Problem 20357 20357
Obstruction of Flow 19174 19174
Battery Problem 18148 18148
Material Integrity Problem 16160 16160
Device Alarm System 15734 15734
Pumping Stopped 15457 15457
Device Operates Differently Than Expected 15243 24914
Connection Problem 13077 13077
Wireless Communication Problem 9254 9254
Incorrect Measurement 8986 8986
Appropriate Term/Code Not Available 8951 8951
No Apparent Adverse Event 8773 8773
Moisture or Humidity Problem 8117 8117
Image Display Error/Artifact 8062 8062
Circuit Failure 7952 7952
Charging Problem 7929 7929
Crack 6668 6668
Moisture Damage 6655 6655
Display or Visual Feedback Problem 5995 5995
Failure to Cycle 5517 5517
Premature Discharge of Battery 5490 5490
Electrical /Electronic Property Problem 4816 4816
Communication or Transmission Problem 4740 4740
Insufficient Information 4541 4541
Failure to Sense 4489 4489
Insufficient Flow or Under Infusion 4285 4285
Detachment of Device or Device Component 4101 4101
Device Inoperable 3802 3802
Fail-Safe Problem 3688 3688
Imprecision 3365 3365
Visual Prompts will not Clear 3072 3072
Failure to Read Input Signal 3041 3041
Computer Software Problem 3038 3038
Priming Problem 2991 2991
Filling Problem 2756 2756
Loose or Intermittent Connection 2747 2747
False Alarm 2672 2672
Component Missing 2667 2667
Use of Device Problem 2463 2463
Failure to Deliver 2369 2369
Detachment Of Device Component 2147 2147
Device Sensing Problem 2089 2089
Excess Flow or Over-Infusion 1962 1962
Physical Resistance/Sticking 1958 1958
Bent 1826 1826
Loss of Data 1814 1814
Failure of Device to Self-Test 1808 1808
Date/Time-Related Software Problem 1636 1636
Failure to Prime 1576 1576
Occlusion Within Device 1548 1548
Material Protrusion/Extrusion 1353 1353
Partial Blockage 1300 1300
Component Falling 1285 1285
Loss of Power 1252 1252
Leak/Splash 1245 1245
Inappropriate or Unexpected Reset 1148 1148
Data Problem 984 984
Unintended Movement 943 943
Fluid/Blood Leak 912 912
High Test Results 839 839
Poor Quality Image 823 823
Application Interface Becomes Non-Functional Or Program Exits Abnormally 797 797
Sticking 792 792
Mechanical Jam 773 773
Failure to Power Up 748 748
Temperature Problem 685 685
Scratched Material 671 671
Device Markings/Labelling Problem 637 637
Improper or Incorrect Procedure or Method 636 636
Inaccurate Delivery 618 618
Defective Component 617 617
Human-Device Interface Problem 579 579
Defective Alarm 572 572
Noise, Audible 571 571
Low Battery 556 556
Fitting Problem 523 523
Air Leak 501 501
Device Slipped 493 493
Device Issue 457 457
Unexpected Therapeutic Results 408 408
Improper Flow or Infusion 403 403
Retraction Problem 372 372
Environmental Compatibility Problem 351 351
Material Separation 346 346
Intermittent Communication Failure 327 327
Material Deformation 318 318
Incorrect Or Inadequate Test Results 308 308
Unexpected Shutdown 292 292
Invalid Sensing 290 290
Physical Property Issue 283 283
Vibration 280 280
Reset Problem 279 279

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 268801 295143
No Clinical Signs, Symptoms or Conditions 79272 79272
Hyperglycemia 77364 77364
No Known Impact Or Consequence To Patient 59008 59008
Insufficient Information 30652 30652
Hypoglycemia 15477 15477
Diabetic Ketoacidosis 4188 4188
Nausea 1234 1234
Vomiting 1130 1130
Death 706 706
Loss of consciousness 501 501
Abdominal Pain 376 376
No Information 349 349
Polydipsia 315 315
Blood Loss 278 278
No Patient Involvement 236 236
Headache 232 232
Dyspnea 217 217
Coma 216 216
Pain 189 189
Confusion/ Disorientation 172 173
Dehydration 169 169
Dizziness 160 160
Seizures 155 155
Unspecified Infection 154 154
Complaint, Ill-Defined 153 153
Fatigue 131 131
No Code Available 119 119
Urinary Frequency 112 112
Fall 107 107
Chest Pain 87 87
Unspecified Tissue Injury 84 84
Skin Irritation 79 79
Lethargy 76 76
Blurred Vision 76 76
Discomfort 74 74
Sweating 66 66
Shaking/Tremors 64 64
Bruise/Contusion 56 56
Cardiac Arrest 55 55
Stroke/CVA 49 49
Overdose 49 49
Myocardial Infarction 46 46
Renal Failure 46 46
Weakness 46 46
Malaise 38 38
Swelling 38 38
Pneumonia 37 37
Ambulation Difficulties 36 37
Diarrhea 34 34
Fever 33 33
Urinary Tract Infection 32 32
Itching Sensation 27 27
Fainting 27 27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 27 27
Hemorrhage/Bleeding 26 26
Irritation 26 26
Skin Inflammation 25 25
Reaction, Injection Site 23 23
Shock, Insulin 23 23
Anxiety 23 23
Syncope 23 23
Rash 22 22
Respiratory Distress 22 22
Scar Tissue 21 21
Bone Fracture(s) 21 21
Cognitive Changes 21 21
Heart Failure 20 20
Congestive Heart Failure 19 19
Low Blood Pressure/ Hypotension 19 19
Head Injury 18 18
Cancer 18 18
Memory Loss/Impairment 17 17
Extreme Exhaustion 15 15
Pregnancy 15 15
Injury 14 14
Neuropathy 14 14
Hypersensitivity/Allergic reaction 14 14
High Blood Pressure/ Hypertension 13 13
Muscle Weakness 13 13
Erythema 13 13
Convulsion/Seizure 13 13
Cramp(s) 12 12
Burn(s) 12 12
Virus 12 12
Tachycardia 11 11
Oversedation 11 11
Chills 11 11
Visual Impairment 11 11
Convulsion, Clonic 11 11
Foreign Body In Patient 11 11
Dysphasia 10 11
Palpitations 9 9
Purulent Discharge 9 9
Hematoma 9 9
Scarring 8 8
Diaphoresis 8 8
Brain Injury 8 8
Burning Sensation 7 7
Reaction 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. II Mar-26-2020
2 Medtronic MiniMed II Nov-08-2022
3 Medtronic MiniMed II Jul-08-2022
4 Tandem Diabetes Care Inc II Jul-18-2018
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