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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
11 5 3 4 3 1

MDR Year MDR Reports MDR Events
2019 3231 3231
2020 7221 7221
2021 69065 69065
2022 15548 15548
2023 10611 10611
2024 1348 1348

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 91329 91329
Device Displays Incorrect Message 3495 3495
Unable to Obtain Readings 3369 3369
High Readings 2858 2858
Appropriate Term/Code Not Available 2809 2809
Low Readings 2169 2169
Detachment of Device or Device Component 1091 1091
Application Program Problem 1012 1012
Adverse Event Without Identified Device or Use Problem 959 959
Product Quality Problem 892 892
Device Alarm System 401 401
Failure to Power Up 278 278
No Device Output 99 99
Material Twisted/Bent 51 51
Failure to Fire 43 43
Difficult to Insert 42 42
Premature Discharge of Battery 36 36
Insufficient Information 34 34
Computer Software Problem 31 31
Power Problem 26 26
Data Problem 26 26
Display or Visual Feedback Problem 18 18
Defective Device 18 18
Battery Problem 18 18
Application Program Version or Upgrade Problem 15 15
Patient-Device Incompatibility 15 15
Therapeutic or Diagnostic Output Failure 15 15
Key or Button Unresponsive/not Working 15 15
Unintended Electrical Shock 13 13
No Display/Image 13 13
Component Missing 12 12
Output Problem 11 11
No Audible Alarm 10 10
Break 9 9
Failure to Charge 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
Packaging Problem 8 8
Crack 8 8
Communication or Transmission Problem 7 7
Activation Failure 6 6
Patient Device Interaction Problem 6 6
Device Fell 6 6
Firing Problem 5 5
Connection Problem 5 5
Device Sensing Problem 5 5
Compatibility Problem 5 5
Device Damaged Prior to Use 5 5
Failure to Discharge 5 5
Display Difficult to Read 5 5
Erratic or Intermittent Display 5 5
Mechanical Problem 4 4
Material Separation 4 4
Defective Component 4 4
Failure to Deliver 4 4
Use of Device Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
No Apparent Adverse Event 4 4
Protective Measures Problem 4 4
Device-Device Incompatibility 3 3
Loss of Data 3 3
Difficult or Delayed Activation 3 3
Low Test Results 3 3
Misfire 3 3
Failure to Sense 3 3
Device Slipped 3 3
Labelling, Instructions for Use or Training Problem 3 3
Failure to Run on Battery 3 3
Fire 3 3
Loss of or Failure to Bond 3 3
Image Display Error/Artifact 2 2
Nonstandard Device 2 2
Charging Problem 2 2
Material Protrusion/Extrusion 2 2
Missing Test Results 2 2
Explosion 2 2
Activation Problem 2 2
Complete Loss of Power 1 1
Excessive Heating 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Problem with Software Installation 1 1
Delivered as Unsterile Product 1 1
Incorrect Measurement 1 1
Unsealed Device Packaging 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Premature End-of-Life Indicator 1 1
Unintended Power Up 1 1
Use of Incorrect Control/Treatment Settings 1 1
Accessory Incompatible 1 1
Delayed Alarm 1 1
Retraction Problem 1 1
Device Contamination with Body Fluid 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Structural Problem 1 1
Failure to Calibrate 1 1
Calibration Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88738 88738
Hypoglycemia 5190 5190
No Known Impact Or Consequence To Patient 4392 4392
Loss of consciousness 4070 4070
Hyperglycemia 2222 2222
Skin Irritation 1878 1878
Erythema 1226 1226
Itching Sensation 1157 1157
Convulsion/Seizure 1049 1049
Unspecified Infection 941 941
Dizziness 939 939
Insufficient Information 855 855
Pain 741 741
Diaphoresis 692 692
Shaking/Tremors 689 689
Skin Infection 521 521
Skin Inflammation/ Irritation 410 410
Diabetic Ketoacidosis 404 404
Vomiting 381 381
Confusion/ Disorientation 357 357
Purulent Discharge 351 351
Fatigue 342 342
Headache 326 326
Sweating 312 312
Rash 300 300
Nausea 265 265
Seizures 221 221
Swelling 203 203
Muscle Weakness 160 160
No Information 153 153
Malaise 151 151
Swelling/ Edema 144 144
Burn(s) 143 143
Weakness 135 135
Fluid Discharge 134 134
Blurred Vision 131 131
Polydipsia 123 123
Bruise/Contusion 115 115
Discomfort 109 109
Hypersensitivity/Allergic reaction 98 98
Device Embedded In Tissue or Plaque 95 95
Burning Sensation 93 93
Hemorrhage/Bleeding 87 87
Skin Inflammation 82 82
Abscess 74 74
Inflammation 64 64
Coma 62 62
Fall 58 58
Lethargy 52 52
Dehydration 50 50
Fever 39 39
Electric Shock 36 36
Fainting 34 34
Tachycardia 34 34
Abdominal Pain 33 33
Foreign Body In Patient 30 30
Chills 29 29
Cramp(s) /Muscle Spasm(s) 21 21
Skin Burning Sensation 20 20
Caustic/Chemical Burns 20 20
Numbness 18 18
Hot Flashes/Flushes 17 17
Scarring 17 17
Blister 16 16
Cognitive Changes 15 15
Urinary Frequency 15 15
Tingling 14 14
No Code Available 14 14
Skin Discoloration 14 14
Cellulitis 13 13
Anxiety 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Hematoma 12 12
Diarrhea 11 11
Balance Problems 11 11
Palpitations 11 11
Pallor 10 10
Discharge 10 10
Dyspnea 10 10
Chest Pain 10 10
Peeling 10 10
Visual Impairment 9 9
Blood Loss 8 8
Edema 8 8
Shock from Patient Lead(s) 7 7
No Consequences Or Impact To Patient 7 7
Skin Erosion 6 6
Vertigo 6 6
High Blood Pressure/ Hypertension 5 5
Paralysis 5 5
Cramp(s) 5 5
Loss of Vision 5 5
Reaction 4 4
Partial thickness (Second Degree) Burn 4 4
Burn, Thermal 4 4
Abdominal Cramps 4 4
Irritation 4 4
Hypoglycemic Shock 4 4
Contact Dermatitis 3 3
Undesired Nerve Stimulation 3 3

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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