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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)
2020 2021 2022 2023 2024 2025
5 3 4 3 1 0

MDR Year MDR Reports MDR Events
2020 7221 7221
2021 69065 69065
2022 15548 15548
2023 10612 10612
2024 4938 4938
2025 986 986

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 94485 94485
Unable to Obtain Readings 3733 3733
Device Displays Incorrect Message 3512 3512
High Readings 2571 2571
Low Readings 2012 2012
Application Program Problem 1337 1337
Appropriate Term/Code Not Available 1062 1062
Adverse Event Without Identified Device or Use Problem 1060 1060
Detachment of Device or Device Component 977 977
Product Quality Problem 923 923
Device Alarm System 665 665
Failure to Power Up 256 256
No Device Output 88 88
Material Twisted/Bent 49 49
Failure to Fire 46 46
Difficult to Insert 42 42
Premature Discharge of Battery 40 40
Computer Software Problem 33 33
Insufficient Information 32 32
Power Problem 23 23
Display or Visual Feedback Problem 19 19
Unintended Electrical Shock 18 18
Defective Device 18 18
Key or Button Unresponsive/not Working 16 16
Component Missing 15 15
Battery Problem 15 15
Application Program Version or Upgrade Problem 15 15
Therapeutic or Diagnostic Output Failure 15 15
No Display/Image 12 12
Output Problem 11 11
No Audible Alarm 10 10
Data Problem 9 9
Patient-Device Incompatibility 9 9
Break 9 9
Failure to Charge 9 9
Application Program Freezes, Becomes Nonfunctional 8 8
Crack 8 8
Activation, Positioning or Separation Problem 8 8
Packaging Problem 8 8
Patient Device Interaction Problem 7 7
Communication or Transmission Problem 7 7
Activation Failure 6 6
No Apparent Adverse Event 6 6
Manufacturing, Packaging or Shipping Problem 5 5
Device Fell 5 5
Connection Problem 5 5
Display Difficult to Read 5 5
Firing Problem 5 5
Device Sensing Problem 5 5
Loss of Data 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 92166 92166
Hypoglycemia 5119 5119
No Known Impact Or Consequence To Patient 4224 4224
Loss of consciousness 4174 4174
Hyperglycemia 1998 1998
Convulsion/Seizure 1221 1221
Insufficient Information 939 939
Dizziness 914 914
Diaphoresis 799 799
Shaking/Tremors 667 667
Skin Irritation 617 617
Skin Infection 579 579
Pain 565 565
Itching Sensation 521 521
Erythema 506 506
Skin Inflammation/ Irritation 449 449
Unspecified Infection 435 435
Fatigue 408 408
Confusion/ Disorientation 349 349
Headache 318 318
Vomiting 304 304
Diabetic Ketoacidosis 302 302
Nausea 220 220
Purulent Discharge 210 210
Swelling/ Edema 169 169
Sweating 164 164
Muscle Weakness 158 158
Seizures 143 143
Malaise 125 125
Blurred Vision 124 124
Rash 122 122
Hypersensitivity/Allergic reaction 112 112
Polydipsia 107 107
Hemorrhage/Bleeding 95 95
Swelling 90 90
Discomfort 88 88
Device Embedded In Tissue or Plaque 82 82
Bruise/Contusion 80 80
No Information 74 74
Abscess 68 68
Fluid Discharge 65 65
Burn(s) 56 56
Fall 52 52
Coma 51 51
Lethargy 50 50
Weakness 50 50
Burning Sensation 46 46
Dehydration 34 34
Electric Shock 34 34
Tachycardia 32 32

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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