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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
Definition A subcutaneous factory calibrated, non-adjunctive, invasive, passive monitoring glucose sensor is intended to determine glucose levels and the direction and rate of change of glucose levels in people with diabetes. Calibrated at the point of manufacture and does not require or accept any user-entered calibration. Monitors glucose levels passively and only provides information, including alarms and alerts, in response to a user initiated action. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions and also provides historical glucose information, facilitating long-term therapy adjustments.
Product CodePZE
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
3 4 3 1 1 0

MDR Year MDR Reports MDR Events
2021 69065 69110
2022 15542 15575
2023 10607 10619
2024 4934 4936
2025 1592 1592
2026 1024 1024

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 91024 91039
Unable to Obtain Readings 3473 3479
Device Displays Incorrect Message 3102 3107
High Readings 2373 2374
Low Readings 1731 1732
Application Program Problem 1417 1419
Adverse Event Without Identified Device or Use Problem 1094 1094
Product Quality Problem 884 893
Detachment of Device or Device Component 796 802
Device Alarm System 715 720
Failure to Power Up 207 207
No Device Output 73 73
Material Twisted/Bent 48 48
Premature Discharge of Battery 39 39
Difficult to Insert 38 38
Failure to Fire 38 38
Computer Software Problem 34 34
Insufficient Information 26 26
Power Problem 20 20
Unintended Electrical Shock 19 19
Display or Visual Feedback Problem 18 18
Defective Device 17 32
Activation, Positioning or Separation Problem 16 16
Key or Button Unresponsive/not Working 16 16
Component Missing 15 21
Therapeutic or Diagnostic Output Failure 13 22
Application Program Version or Upgrade Problem 13 13
Output Problem 11 24
Battery Problem 10 10
No Audible Alarm 9 9
Packaging Problem 8 8
Appropriate Term/Code Not Available 8 8
Communication or Transmission Problem 8 8
No Apparent Adverse Event 7 7
Application Program Freezes, Becomes Nonfunctional 7 7
No Display/Image 7 7
Break 7 9
Activation Failure 6 10
Data Problem 6 6
Patient Device Interaction Problem 6 14
Failure to Charge 6 6
Device Sensing Problem 5 6
Manufacturing, Packaging or Shipping Problem 5 6
Connection Problem 5 5
Compatibility Problem 5 5
Loss of Data 5 5
Material Separation 4 4
Protective Measures Problem 4 8
Use of Device Problem 4 4
Failure to Deliver 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92973 93010
Hypoglycemia 4532 4544
Loss of consciousness 3772 3776
Hyperglycemia 1601 1604
Convulsion/Seizure 1244 1245
Insufficient Information 1016 1046
Diaphoresis 820 821
Dizziness 813 813
Skin Infection 593 593
Shaking/Tremors 582 582
Skin Inflammation/ Irritation 446 446
Pain 396 403
Fatigue 360 362
Confusion/ Disorientation 303 303
Headache 275 275
Vomiting 220 221
Diabetic Ketoacidosis 208 209
Itching Sensation 171 171
Swelling/ Edema 170 170
Nausea 165 165
Muscle Weakness 157 157
Erythema 134 134
Hypersensitivity/Allergic reaction 115 122
Purulent Discharge 101 101
Malaise 101 101
Hemorrhage/Bleeding 97 98
Blurred Vision 94 94
Polydipsia 83 83
Device Embedded In Tissue or Plaque 65 65
Discomfort 61 62
Bruise/Contusion 50 50
Lethargy 48 48
Fall 41 41
Fluid Discharge 39 39
Abscess 37 37
Coma 36 36
Electric Shock 31 31
Rash 27 27
Hot Flashes/Flushes 26 26
Chills 25 25
Tachycardia 25 25
Cognitive Changes 23 23
Foreign Body In Patient 23 23
Cramp(s) /Muscle Spasm(s) 21 21
Skin Burning Sensation 20 21
Blister 20 20
Dehydration 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Numbness 15 15
Fever 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. I Apr-06-2023
2 Cardinal Health Inc. II Jun-23-2021
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