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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)
2019 2020 2021 2022 2023 2024 2025
11 5 3 4 3 1 1

MDR Year MDR Reports MDR Events
2019 3231 3245
2020 7222 7235
2021 69065 69110
2022 15542 15575
2023 10607 10619
2024 4934 4936
2025 1516 1516

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 95010 95032
Device Displays Incorrect Message 3837 3843
Unable to Obtain Readings 3762 3768
High Readings 2958 2961
Appropriate Term/Code Not Available 2809 2809
Low Readings 2409 2410
Application Program Problem 1377 1379
Detachment of Device or Device Component 1130 1136
Adverse Event Without Identified Device or Use Problem 1076 1088
Product Quality Problem 979 989
Device Alarm System 691 696
Failure to Power Up 296 296
No Device Output 111 111
Material Twisted/Bent 53 53
Failure to Fire 48 48
Difficult to Insert 42 42
Premature Discharge of Battery 40 40
Insufficient Information 35 35
Computer Software Problem 33 33
Power Problem 27 27
Data Problem 26 26
Display or Visual Feedback Problem 19 19
Battery Problem 19 19
Defective Device 19 34
Unintended Electrical Shock 18 18
Key or Button Unresponsive/not Working 16 16
Component Missing 15 21
Patient-Device Incompatibility 15 17
Application Program Version or Upgrade Problem 15 15
Therapeutic or Diagnostic Output Failure 15 26
No Display/Image 14 14
Output Problem 11 24
No Audible Alarm 10 10
Communication or Transmission Problem 10 11
Failure to Charge 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
Break 9 11
Activation, Positioning or Separation Problem 8 8
Crack 8 8
Packaging Problem 8 8
Patient Device Interaction Problem 7 15
No Apparent Adverse Event 7 7
Manufacturing, Packaging or Shipping Problem 6 7
Device Fell 6 6
Activation Failure 6 10
Failure to Discharge 5 5
Loss of Data 5 5
Compatibility Problem 5 5
Firing Problem 5 5
Connection Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92543 92580
Hypoglycemia 5840 5855
Loss of consciousness 4625 4629
No Known Impact Or Consequence To Patient 4392 4399
Hyperglycemia 2427 2433
Skin Irritation 1878 1878
Erythema 1244 1244
Convulsion/Seizure 1238 1239
Itching Sensation 1170 1179
Dizziness 1059 1059
Insufficient Information 967 997
Unspecified Infection 941 941
Diaphoresis 807 808
Pain 793 800
Shaking/Tremors 753 753
Skin Infection 586 586
Fatigue 452 454
Skin Inflammation/ Irritation 452 452
Diabetic Ketoacidosis 429 430
Vomiting 419 420
Confusion/ Disorientation 400 400
Purulent Discharge 378 378
Headache 367 367
Sweating 312 312
Rash 306 310
Nausea 281 281
Seizures 221 221
Swelling 203 203
Swelling/ Edema 171 171
Muscle Weakness 160 160
Blurred Vision 153 153
No Information 153 153
Malaise 151 151
Burn(s) 145 146
Fluid Discharge 136 136
Weakness 135 135
Polydipsia 130 130
Bruise/Contusion 121 121
Discomfort 118 119
Hypersensitivity/Allergic reaction 115 122
Device Embedded In Tissue or Plaque 104 104
Hemorrhage/Bleeding 99 100
Burning Sensation 94 99
Abscess 84 84
Skin Inflammation 82 82
Inflammation 64 64
Coma 62 62
Fall 58 58
Dehydration 56 56
Lethargy 52 52

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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