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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 , threshold suspend
Definition An automated insulin dosing system that temporarily suspends or reduces insulin infusion from an insulin pump based upon specified thresholds of measured glucose levels.
Product CodeOZO
Device Class 3

Premarket Approvals (PMA)
2015 2016 2017 2018 2019 2020
35 28 29 53 31 4

Device Problems
Patient Device Interaction Problem 24812
Adverse Event Without Identified Device or Use Problem 19019
Device Displays Incorrect Message 18230
Obstruction of Flow 16030
Pumping Stopped 12273
No Apparent Adverse Event 11484
Device Difficult to Program or Calibrate 9950
Mechanical Problem 9851
Power Problem 9204
No Display/Image 7700
Incorrect Measurement 7532
Battery Problem 6546
Physical Resistance/Sticking 4744
Connection Problem 4525
Charging Problem 4493
Appropriate Term/Code Not Available 3887
Filling Problem 3601
Display or Visual Feedback Problem 3376
Failure to Sense 3317
Device Alarm System 3315
Incorrect, Inadequate or Imprecise Resultor Readings 3173
Crack 2478
Data Problem 2448
Moisture or Humidity Problem 2315
Priming Problem 2231
Material Integrity Problem 2127
False Alarm 1974
Use of Device Problem 1902
Insufficient Flow or Under Infusion 1846
Break 1738
Failure to Cycle 1694
Detachment of Device or Device Component 1583
Leak/Splash 1466
Visual Prompts will not Clear 1408
Unexpected Therapeutic Results 1223
Device Sensing Problem 1198
Date/Time-Related Software Problem 1143
Circuit Failure 1117
Partial Blockage 1104
Premature Discharge of Battery 885
Communication or Transmission Problem 883
Insufficient Information 781
Inappropriate or Unexpected Reset 697
Excess Flow or Over-Infusion 672
Wireless Communication Problem 664
Switch, Push Button 590
Calibration Problem 574
Device Operates Differently Than Expected 533
Device Inoperable 512
Poor Quality Image 457
Fitting Problem 439
Computer Software Problem 437
Keypad 401
Material Separation 400
Sensor 389
Electrical /Electronic Property Problem 365
Loss of Data 335
Fracture 305
Loose or Intermittent Connection 289
Failure of Device to Self-Test 285
Mechanical Jam 249
Material Twisted/Bent 249
Intermittent Communication Failure 177
Component Missing 173
Unintended Movement 168
Human-Device Interface Problem 165
Failure to Auto Stop 158
Cannula 157
Temperature Problem 155
Device Markings/Labelling Problem 134
Screen 127
Bent 115
Failure to Deliver 113
Difficult to Remove 104
Incorrect Or Inadequate Test Results 102
Motor(s) 99
Activation Problem 97
Sticking 94
Overheating of Device 89
Material Deformation 87
Electrode 87
Moisture Damage 84
Needle 81
Unexpected Shutdown 79
Improper Flow or Infusion 78
Improper or Incorrect Procedure or Method 74
Cap 71
Detachment Of Device Component 71
Material Frayed 70
Loss of Power 69
Disconnection 68
Device Fell 65
Failure to Power Up 64
Scratched Material 61
Application Interface Becomes Non-Functional Or Program Exits Abnormally 61
Component Falling 59
Environmental Compatibility Problem 58
Self-Activation or Keying 57
Noise, Audible 53
Manufacturing, Packaging or Shipping Problem 53
Total Device Problems 233125

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. I Feb-07-2020
2 Medtronic Inc. II Jul-09-2019
3 Medtronic Inc. II Dec-22-2018
4 Medtronic Inc. II Feb-21-2018

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