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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)
2015 2016 2017 2018 2019 2020
0 7 15 28 21 4

Device Problems
Patient Device Interaction Problem 41713
Adverse Event Without Identified Device or Use Problem 26255
No Apparent Adverse Event 19769
Connection Problem 9622
Power Problem 9457
Appropriate Term/Code Not Available 8937
No Display/Image 8345
Device Alarm System 7077
Mechanical Problem 5525
Device Difficult to Program or Calibrate 5373
Moisture or Humidity Problem 4993
Circuit Failure 3702
Incorrect, Inadequate or Imprecise Resultor Readings 3664
Obstruction of Flow 3029
Display or Visual Feedback Problem 2624
Communication or Transmission Problem 2008
Computer Software Problem 1846
Material Integrity Problem 1760
Unexpected Therapeutic Results 1697
Calibration Problem 1335
Insufficient Flow or Under Infusion 1314
Battery Problem 1158
Excess Flow or Over-Infusion 816
Visual Prompts will not Clear 815
Electrical /Electronic Property Problem 655
Mechanical Jam 538
Insufficient Information 534
Failure of Device to Self-Test 523
Break 455
Loss of Data 433
Unintended Movement 393
Device Markings/Labelling Problem 310
Priming Problem 295
Intermittent Loss of Power 271
Fracture 257
Date/Time-Related Software Problem 202
Difficult to Remove 149
Overheating of Device 143
Human-Device Interface Problem 136
Intermittent Communication Failure 115
Environmental Compatibility Problem 91
Manufacturing, Packaging or Shipping Problem 83
Material Twisted/Bent 70
Activation Problem 27
Use of Device Problem 23
Data Problem 14
Inappropriate or Unexpected Reset 8
Packaging Problem 5
Application Program Problem: Dose Calculation Error 5
Application Program Problem: Medication Error 4
Failure to Calibrate 4
Operating System Becomes Nonfunctional 3
Expulsion 3
Inadequacy of Device Shape and/or Size 2
Unauthorized Access to Computer System 2
Naturally Worn 2
Inaccurate Delivery 2
Low Readings 1
Device Displays Incorrect Message 1
Activation, Positioning or SeparationProblem 1
Infusion or Flow Problem 1
Tip 1
Incorrect Measurement 1
Calibration Error 1
Crack 1
Fluid Leak 1
Chemical Problem 1
Total Device Problems 178601

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. I Feb-07-2020
2 Medtronic Inc. II Jul-09-2019

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