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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)
2015 2016 2017 2018 2019 2020 2021
1 17 13 9 2 0 0

MDR Year MDR Reports MDR Events
2015 105249 105249
2016 96913 96913
2017 132635 138175
2018 106230 119552
2019 99214 106693
2020 74592 74592
2021 14852 14852

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 171679 181350
Patient Device Interaction Problem 67230 67230
No Display/Image 33216 33216
Device Operates Differently Than Expected 32879 42550
Adverse Event Without Identified Device or Use Problem 32141 32141
Structural Problem 23341 23341
Mechanical Problem 20872 33791
Device Difficult to Program or Calibrate 19782 31012
Power Problem 19456 19456
Break 19123 19123
Device Inoperable 17927 17927
Device Alarm System 17819 17819
Battery Problem 17710 17710
Pumping Stopped 16766 16766
Crack 14735 14735
Obstruction of Flow 14718 14718
Moisture Damage 11975 11975
Insufficient Information 11083 11083
Wireless Communication Problem 10924 10924
Connection Problem 10602 10602
Moisture or Humidity Problem 9986 9986
Image Display Error/Artifact 9949 9949
Incorrect Measurement 9547 9547
Failure to Deliver 8699 8699
Appropriate Term/Code Not Available 8384 8384
Charging Problem 8003 8003
No Apparent Adverse Event 7747 7747
Circuit Failure 6527 6527
Premature Discharge of Battery 5512 5512
Bent 5335 5335
Display or Visual Feedback Problem 5131 5131
Electrical /Electronic Property Problem 4807 4807
Failure to Cycle 4544 4544
Visual Prompts will not Clear 4492 4492
Fail-Safe Problem 4426 4426
Communication or Transmission Problem 4397 4397
Component Missing 4242 4242
Failure to Sense 3946 3946
Loose or Intermittent Connection 3749 3749
Insufficient Flow or Under Infusion 3528 3528
Sticking 3525 3525
Failure to Prime 3517 3517
Improper or Incorrect Procedure or Method 3505 3505
Failure to Read Input Signal 3495 3495
Detachment Of Device Component 3467 3467
Material Protrusion/Extrusion 3451 3451
Use of Device Problem 3440 3440
Detachment of Device or Device Component 3408 3408
Imprecision 3363 3363
Loss of Power 3320 3320
Component Falling 3294 3294
Filling Problem 3201 3201
Occlusion Within Device 2833 2833
Scratched Material 2759 2759
Priming Problem 2708 2708
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2564 2564
Fluid Leak 2559 2559
False Alarm 2517 2517
Excess Flow or Over-Infusion 2321 2321
Material Integrity Problem 2304 2304
Self-Activation or Keying 2273 2273
Leak/Splash 2151 2151
Computer Software Problem 2125 2125
Device Sensing Problem 2112 2112
Air Leak 2086 2086
Failure of Device to Self-Test 1940 1940
Physical Resistance/Sticking 1885 1885
Noise, Audible 1820 1820
Partial Blockage 1772 1772
High Test Results 1734 1734
Failure to Power Up 1682 1682
Date/Time-Related Software Problem 1597 1597
Inappropriate or Unexpected Reset 1562 1562
Poor Quality Image 1554 1554
Improper Flow or Infusion 1456 1456
Inaccurate Delivery 1453 1453
Loss of Data 1410 1410
Low Battery 1263 1263
Reset Problem 1185 1185
Data Problem 1168 1168
Retraction Problem 1084 1084
Device Slipped 912 912
Temperature Problem 792 792
Device Stops Intermittently 760 760
Invalid Sensing 726 726
Vibration 713 713
Material Deformation 707 707
Defective Alarm 667 667
Defective Component 660 660
Difficult or Delayed Activation 653 653
Human-Device Interface Problem 644 644
Mechanical Jam 641 641
Electromagnetic Interference 627 627
Incorrect Or Inadequate Test Results 620 620
Fitting Problem 602 602
Device Issue 578 578
Erratic or Intermittent Display 572 572
Use of Incorrect Control Settings 565 565
Unintended Collision 550 550
Corroded 536 536

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 285847 312188
Hyperglycemia 166081 166081
No Known Impact Or Consequence To Patient 135457 135457
Hypoglycemia 29417 29417
Diabetic Ketoacidosis 8811 8811
Insufficient Information 7712 7712
No Clinical Signs, Symptoms or Conditions 6440 6440
Vomiting 2982 2982
Nausea 2926 2926
No Information 1748 1748
Death 1481 1481
Loss of consciousness 1289 1289
Polydipsia 1177 1177
Headache 703 703
Abdominal Pain 682 682
Underdose 628 628
Unspecified Infection 607 607
Fall 586 586
Dizziness 572 572
Fatigue 543 543
Pain 534 534
Complaint, Ill-Defined 530 530
No Code Available 520 520
Urinary Frequency 518 518
Dehydration 508 508
Dyspnea 503 503
Sweating 470 470
Seizures 468 468
Overdose 450 450
Coma 431 431
Confusion/ Disorientation 396 397
No Patient Involvement 362 362
Blood Loss 311 311
Chest Pain 301 301
Malaise 301 301
Weakness 223 223
Lethargy 217 217
Shaking/Tremors 207 207
Hemorrhage/Bleeding 202 202
Blurred Vision 193 193
Myocardial Infarction 185 185
Cardiac Arrest 168 168
Renal Failure 166 166
Stroke/CVA 163 163
Pneumonia 162 162
Diarrhea 146 146
Respiratory Distress 136 136
Urinary Tract Infection 127 127
Skin Irritation 122 122
Swelling 116 116
Ambulation Difficulties 102 103
Scar Tissue 94 94
Injury 84 84
Discomfort 84 84
Erythema 84 84
Fainting 82 82
Tachycardia 81 81
Bruise/Contusion 80 80
Syncope 77 77
Bone Fracture(s) 75 75
Fever 75 75
High Blood Pressure/ Hypertension 71 71
Irritation 71 71
Itching Sensation 70 70
Neuropathy 62 62
Cognitive Changes 62 62
Reaction 60 60
Irritability 59 59
Congestive Heart Failure 59 59
Rash 59 59
Heart Failure 58 58
Anxiety 55 55
Numbness 55 55
Cancer 55 55
Head Injury 52 52
Cramp(s) 45 45
Memory Loss/Impairment 44 44
Visual Impairment 44 44
Scarring 42 42
Virus 40 40
Skin Inflammation 36 36
Sleep Dysfunction 36 36
Collapse 35 35
Palpitations 35 35
Hypersensitivity/Allergic reaction 34 34
Low Blood Pressure/ Hypotension 34 34
Burning Sensation 33 33
Dysphasia 31 32
Pregnancy 31 31
Respiratory Failure 29 29
Tingling 29 29
Bronchitis 28 28
Foreign Body In Patient 28 28
Sepsis 28 28
Weight Changes 27 27
Purulent Discharge 26 26
Extreme Exhaustion 26 26
Shock, Insulin 26 26
Reaction, Injection Site 26 26
Chills 25 25

Recalls
Manufacturer Recall Class Date Posted
1 Animas Corporation II Jan-30-2015
2 Medtronic Inc. II Mar-26-2020
3 Medtronic MiniMed Inc. II Dec-17-2015
4 Tandem Diabetes Care Inc II Jul-18-2018
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