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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device insulin pump secondary display
Regulation Description Continuous glucose monitor secondary alarm system.
Definition The purpose of the insulin pump secondary display is to notify another person of the patient's insulin pump usage information in real time. The secondary display is intended for providing secondary notification of insulin pump usage and does not replace primary real time insulin pump monitoring or standard home blood glucose monitoring.
Product CodePKU
Regulation Number 862.1350
Device Class 2

MDR Year MDR Reports MDR Events
2022 6036 6045
2023 10083 10086
2024 9648 9654
2025 12023 12023
2026 164 164

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 30013 30025
Computer Software Problem 9575 9581
Appropriate Term/Code Not Available 1578 1579
Communication or Transmission Problem 1094 1095
Application Network Problem 127 127
Device Alarm System 97 97
Problem with Software Installation 46 46
No Apparent Adverse Event 36 36
Data Problem 35 35
Unauthorized Access to Computer System 13 13
Adverse Event Without Identified Device or Use Problem 4 4
Break 3 3
Application Program Problem 3 3
Battery Problem 3 3
Power Problem 2 2
Application Program Version or Upgrade Problem 1 1
Material Integrity Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Key or Button Unresponsive/not Working 1 1
Use of Device Problem 1 1
Moisture or Humidity Problem 1 1
Erratic or Intermittent Display 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37070 37086
Insufficient Information 521 521
Hyperglycemia 189 190
Hypoglycemia 129 129
Hemorrhage/Bleeding 26 26
Discomfort 20 20
Bruise/Contusion 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Diabetic Ketoacidosis 6 6
Confusion/ Disorientation 3 3
Unspecified Infection 2 2
Skin Inflammation/ Irritation 2 2
Itching Sensation 2 2
Dehydration 2 2
Pain 2 2
Urinary Frequency 2 2
Loss of consciousness 2 2
Abdominal Pain 1 1
Skin Infection 1 1
Convulsion, Clonic 1 1
Fatigue 1 1
Nausea 1 1
Hematoma 1 1
Malaise 1 1
Vomiting 1 1
Respiratory Tract Infection 1 1
Dyspnea 1 1
Paresis 1 1
Pneumonia 1 1
Anxiety 1 1
Shaking/Tremors 1 1
Hypoglycemic Shock 1 1
Joint Contracture 1 1
Headache 1 1

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