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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 2773 2773

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 92427 92427
Device Displays Incorrect Message 3565 3565
Unable to Obtain Readings 3438 3438
High Readings 2880 2880
Appropriate Term/Code Not Available 2809 2809
Low Readings 2232 2232
Detachment of Device or Device Component 1104 1104
Application Program Problem 1090 1090
Adverse Event Without Identified Device or Use Problem 983 983
Product Quality Problem 914 914
Device Alarm System 480 480
Failure to Power Up 280 280
No Device Output 100 100
Material Twisted/Bent 51 51
Failure to Fire 45 45
Difficult to Insert 42 42
Premature Discharge of Battery 37 37
Insufficient Information 34 34
Computer Software Problem 33 33
Power Problem 26 26
Data Problem 26 26
Display or Visual Feedback Problem 18 18
Defective Device 18 18
Battery Problem 18 18
Patient-Device Incompatibility 15 15
Application Program Version or Upgrade Problem 15 15
Therapeutic or Diagnostic Output Failure 15 15
Key or Button Unresponsive/not Working 15 15
Unintended Electrical Shock 14 14
Component Missing 13 13
No Display/Image 13 13
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
Device Fell 6 6
Activation Failure 6 6
Patient Device Interaction Problem 6 6
Firing Problem 5 5
Device Sensing Problem 5 5
Compatibility Problem 5 5
Connection 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
Defective Component 4 4
Material Separation 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
Low Test Results 3 3
Failure to Sense 3 3
Device Slipped 3 3
Loss of Data 3 3
Activation, Positioning or Separation Problem 3 3
Difficult or Delayed Activation 3 3
Misfire 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
Device Markings/Labelling Problem 2 2
Charging Problem 2 2
Material Protrusion/Extrusion 2 2
Missing Test Results 2 2
Explosion 2 2
Activation Problem 2 2
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Complete Loss of Power 1 1
Excessive Heating 1 1
Problem with Software Installation 1 1
Difficult to Open or Close 1 1
Material Deformation 1 1
Calibration Problem 1 1
Failure to Disconnect 1 1
Separation Failure 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Structural Problem 1 1
Failure to Calibrate 1 1
Device Contamination with Body Fluid 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Incorrect Measurement 1 1
Premature End-of-Life Indicator 1 1
Retraction Problem 1 1
Imprecision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89868 89868
Hypoglycemia 5332 5332
No Known Impact Or Consequence To Patient 4392 4392
Loss of consciousness 4192 4192
Hyperglycemia 2281 2281
Skin Irritation 1878 1878
Erythema 1230 1230
Itching Sensation 1162 1162
Convulsion/Seizure 1097 1097
Dizziness 969 969
Unspecified Infection 941 941
Insufficient Information 878 878
Pain 755 755
Diaphoresis 719 719
Shaking/Tremors 704 704
Skin Infection 536 536
Skin Inflammation/ Irritation 421 421
Diabetic Ketoacidosis 406 406
Vomiting 388 388
Fatigue 368 368
Confusion/ Disorientation 366 366
Purulent Discharge 356 356
Headache 337 337
Sweating 312 312
Rash 303 303
Nausea 269 269
Seizures 221 221
Swelling 203 203
Muscle Weakness 160 160
No Information 153 153
Swelling/ Edema 152 152
Malaise 151 151
Burn(s) 143 143
Blurred Vision 137 137
Weakness 135 135
Fluid Discharge 134 134
Polydipsia 126 126
Bruise/Contusion 115 115
Discomfort 111 111
Hypersensitivity/Allergic reaction 102 102
Device Embedded In Tissue or Plaque 100 100
Burning Sensation 94 94
Hemorrhage/Bleeding 90 90
Skin Inflammation 82 82
Abscess 77 77
Inflammation 64 64
Coma 62 62
Fall 58 58
Lethargy 52 52
Dehydration 50 50
Fever 39 39
Tachycardia 36 36
Electric Shock 36 36
Fainting 34 34
Abdominal Pain 33 33
Foreign Body In Patient 30 30
Chills 29 29
Cognitive Changes 21 21
Cramp(s) /Muscle Spasm(s) 21 21
Skin Burning Sensation 20 20
Caustic/Chemical Burns 20 20
Numbness 19 19
Hot Flashes/Flushes 17 17
Scarring 17 17
Blister 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Urinary Frequency 15 15
Tingling 14 14
Skin Discoloration 14 14
No Code Available 14 14
Anxiety 13 13
Cellulitis 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
Edema 8 8
Blood Loss 8 8
Shock from Patient Lead(s) 7 7
No Consequences Or Impact To Patient 7 7
Vertigo 6 6
Skin Erosion 6 6
Cramp(s) 5 5
High Blood Pressure/ Hypertension 5 5
Loss of Vision 5 5
Paralysis 5 5
Irritation 4 4
Reaction 4 4
Partial thickness (Second Degree) Burn 4 4
Burn, Thermal 4 4
Abdominal Cramps 4 4
Hypoglycemic Shock 4 4
Contact Dermatitis 3 3
Collapse 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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