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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)
2018 2019 2020 2021 2022 2023
9 2 0 0 0 0

MDR Year MDR Reports MDR Events
2018 106241 119563
2019 99216 106695
2020 74592 74592
2021 50930 50930
2022 78205 78205
2023 10949 10949

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 70567 70567
Break 62076 62076
Power Problem 33877 33877
Mechanical Problem 25859 38778
Device Difficult to Program or Calibrate 24187 35417
Obstruction of Flow 20338 20338
Material Integrity Problem 18647 18647
No Display/Image 18367 18367
Battery Problem 17945 17945
Adverse Event Without Identified Device or Use Problem 17537 17537
Device Displays Incorrect Message 17127 21258
Device Alarm System 15106 15106
Connection Problem 13256 13256
Pumping Stopped 12661 12661
Structural Problem 10963 10963
Appropriate Term/Code Not Available 9451 9451
No Apparent Adverse Event 8832 8832
Circuit Failure 8160 8160
Incorrect Measurement 7281 7281
Moisture or Humidity Problem 7148 7148
Wireless Communication Problem 6979 6979
Charging Problem 6902 6902
Display or Visual Feedback Problem 6253 6253
Failure to Cycle 5772 5772
Communication or Transmission Problem 4792 4792
Premature Discharge of Battery 4773 4773
Insufficient Flow or Under Infusion 4337 4337
Detachment of Device or Device Component 4277 4277
Failure to Sense 4268 4268
Image Display Error/Artifact 3920 3920
Crack 3556 3556
Electrical /Electronic Property Problem 3321 3321
Computer Software Problem 3247 3247
Imprecision 3111 3111
Priming Problem 3081 3081
Visual Prompts will not Clear 2881 2881
Insufficient Information 2592 2592
False Alarm 2485 2485
Filling Problem 2418 2418
Moisture Damage 2359 2359
Device Sensing Problem 2070 2070
Device Operates Differently Than Expected 2028 6159
Physical Resistance/Sticking 1969 1969
Loss of Data 1963 1963
Use of Device Problem 1906 1906
Excess Flow or Over-Infusion 1717 1717
Loose or Intermittent Connection 1710 1710
Fail-Safe Problem 1654 1654
Failure of Device to Self-Test 1554 1554
Date/Time-Related Software Problem 1439 1439
Failure to Read Input Signal 1435 1435
Component Missing 1059 1059
Unintended Movement 1042 1042
Leak/Splash 931 931
Partial Blockage 912 912
Data Problem 883 883
Detachment Of Device Component 842 842
Mechanical Jam 802 802
Device Inoperable 781 781
Inappropriate or Unexpected Reset 725 725
Device Markings/Labelling Problem 668 668
Failure to Prime 648 648
Poor Quality Image 634 634
Human-Device Interface Problem 593 593
Unexpected Therapeutic Results 478 478
Occlusion Within Device 456 456
Failure to Deliver 454 454
Fitting Problem 452 452
Temperature Problem 437 437
Environmental Compatibility Problem 394 394
Loss of Power 366 366
Component Falling 366 366
High Test Results 350 350
Intermittent Communication Failure 341 341
Material Separation 327 327
Unexpected Shutdown 292 292
Material Protrusion/Extrusion 292 292
Fluid/Blood Leak 282 282
Failure to Power Up 272 272
Overheating of Device 260 260
Defective Alarm 242 242
Inaccurate Delivery 229 229
Bent 219 219
Manufacturing, Packaging or Shipping Problem 213 213
Material Deformation 211 211
Improper Flow or Infusion 200 200
Pumping Problem 198 198
Device Slipped 181 181
Sticking 176 176
Low Battery 170 170
Scratched Material 165 165
Nonstandard Device 163 163
Intermittent Loss of Power 154 154
Material Twisted/Bent 146 146
Application Program Version or Upgrade Problem 141 141
Noise, Audible 139 139
Physical Resistance 134 134
Retraction Problem 134 134
Incorrect, Inadequate or Imprecise Result or Readings 121 121
Application Interface Becomes Non-Functional Or Program Exits Abnormally 118 118

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 218047 238849
No Clinical Signs, Symptoms or Conditions 102317 102317
Hyperglycemia 35335 35335
Insufficient Information 30666 30666
No Known Impact Or Consequence To Patient 25824 25824
Hypoglycemia 9381 9381
Diabetic Ketoacidosis 3083 3083
Nausea 803 803
Vomiting 727 727
Death 474 474
Loss of consciousness 347 347
Abdominal Pain 296 296
Blood Loss 212 212
Dyspnea 172 172
No Patient Involvement 172 172
Coma 169 169
Polydipsia 156 156
Headache 152 152
Pain 125 125
Confusion/ Disorientation 119 119
Complaint, Ill-Defined 111 111
Seizures 101 101
Dehydration 99 99
Dizziness 96 96
Unspecified Tissue Injury 84 84
Unspecified Infection 80 80
Fatigue 78 78
Discomfort 65 65
Skin Irritation 60 60
Shaking/Tremors 48 48
No Code Available 48 48
Chest Pain 47 47
Bruise/Contusion 45 45
Urinary Frequency 44 44
Blurred Vision 41 41
Lethargy 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Fall 38 38
Cardiac Arrest 34 34
Sweating 32 32
Fever 28 28
Renal Failure 27 27
Myocardial Infarction 27 27
Stroke/CVA 24 24
Weakness 22 22
Swelling 21 21
Skin Inflammation 21 21
Fainting 20 20
Anxiety 20 20
Reaction, Injection Site 20 20
Shock, Insulin 19 19
Itching Sensation 19 19
Pneumonia 18 18
Diarrhea 18 18
Ambulation Difficulties 17 17
Rash 16 16
Memory Loss/Impairment 15 15
Irritation 15 15
Urinary Tract Infection 14 14
Cancer 14 14
Pregnancy 14 14
Convulsion/Seizure 14 14
No Information 13 13
Low Blood Pressure/ Hypotension 13 13
Hypersensitivity/Allergic reaction 12 12
Convulsion, Clonic 12 12
Malaise 12 12
Heart Failure 12 12
Oversedation 11 11
Head Injury 11 11
Foreign Body In Patient 10 10
Muscle Weakness 10 10
Scar Tissue 9 9
Burn(s) 9 9
Congestive Heart Failure 9 9
Cognitive Changes 9 9
High Blood Pressure/ Hypertension 8 8
Extreme Exhaustion 8 8
Chills 8 8
Bone Fracture(s) 8 8
Brain Injury 7 7
Tachycardia 7 7
Neuropathy 7 7
Hematoma 7 7
Abdominal Cramps 7 7
Viral Infection 6 6
Skin Erosion 6 6
Dysphagia/ Odynophagia 6 6
Erythema 6 6
Palpitations 6 6
Hip Fracture 5 5
Visual Impairment 5 5
Inflammation 5 5
Dementia 5 5
Purulent Discharge 5 5
Joint Contracture 5 5
Syncope/Fainting 4 4
Diaphoresis 4 4
Collapse 4 4
Nerve Damage 4 4

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