Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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)
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 8 18 11 5 3 4 3 1

MDR Year MDR Reports MDR Events
2017 63 63
2018 2094 2094
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 91441 91441
Appropriate Term/Code Not Available 4085 4085
Device Displays Incorrect Message 3678 3678
Unable to Obtain Readings 3371 3371
High Readings 3101 3101
Low Readings 2371 2371
Detachment of Device or Device Component 1151 1151
Application Program Problem 1012 1012
Adverse Event Without Identified Device or Use Problem 961 961
Product Quality Problem 904 904
Device Alarm System 401 401
Failure to Power Up 290 290
No Device Output 111 111
Material Twisted/Bent 51 51
Failure to Fire 47 47
Difficult to Insert 42 42
Insufficient Information 39 39
Premature Discharge of Battery 37 37
Computer Software Problem 31 31
No Display/Image 29 29
Data Problem 27 27
Power Problem 26 26
Battery Problem 23 23
Display or Visual Feedback Problem 21 21
Defective Device 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
Component Missing 12 12
Output Problem 11 11
No Audible Alarm 10 10
Failure to Charge 9 9
Application Program Freezes, Becomes Nonfunctional 9 9
Break 9 9
Crack 8 8
Packaging Problem 8 8
Communication or Transmission Problem 7 7
Device Fell 6 6
Activation Failure 6 6
Patient Device Interaction Problem 6 6
Failure to Discharge 5 5
Firing Problem 5 5
Erratic or Intermittent Display 5 5
Device Damaged Prior to Use 5 5
Connection Problem 5 5
Misfire 5 5
Display Difficult to Read 5 5
Compatibility Problem 5 5
Device Sensing Problem 5 5
Fire 5 5
Missing Test Results 4 4
Defective Component 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 4 4
Failure to Deliver 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Mechanical Problem 4 4
Material Separation 4 4
Protective Measures Problem 4 4
Image Display Error/Artifact 3 3
Low Test Results 3 3
Device-Device Incompatibility 3 3
Device Slipped 3 3
Labelling, Instructions for Use or Training Problem 3 3
Difficult or Delayed Activation 3 3
Loss of or Failure to Bond 3 3
Failure to Run on Battery 3 3
Loss of Data 3 3
Failure to Sense 3 3
Charging Problem 2 2
Explosion 2 2
Activation Problem 2 2
Premature End-of-Life Indicator 2 2
Nonstandard Device 2 2
Material Protrusion/Extrusion 2 2
Separation Failure 1 1
Use of Incorrect Control/Treatment Settings 1 1
Unsealed Device Packaging 1 1
Under-Sensing 1 1
Delayed Alarm 1 1
Excessive Heating 1 1
Material Deformation 1 1
Detachment Of Device Component 1 1
Inadequacy of Device Shape and/or Size 1 1
Accessory Incompatible 1 1
Physical Resistance/Sticking 1 1
Incorrect Or Inadequate Test Results 1 1
Calibration Problem 1 1
Thermal Decomposition of Device 1 1
Failure to Disconnect 1 1
Complete Loss of Power 1 1
Sharp Edges 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Close 1 1
Structural Problem 1 1
Failure to Calibrate 1 1
Incorrect Measurement 1 1
Smoking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 88739 88739
Hypoglycemia 5673 5673
No Known Impact Or Consequence To Patient 4503 4503
Loss of consciousness 4320 4320
Skin Irritation 2835 2835
Hyperglycemia 2435 2435
Itching Sensation 1546 1546
Erythema 1483 1483
Unspecified Infection 1250 1250
Convulsion/Seizure 1049 1049
Dizziness 992 992
Pain 855 855
Insufficient Information 855 855
Shaking/Tremors 735 735
Diaphoresis 697 697
Skin Infection 522 522
Diabetic Ketoacidosis 451 451
Purulent Discharge 420 420
Vomiting 414 414
Skin Inflammation/ Irritation 410 410
Sweating 385 385
Confusion/ Disorientation 370 370
Fatigue 361 361
Headache 347 347
Rash 343 343
Nausea 293 293
Seizures 280 280
Swelling 239 239
No Information 186 186
Weakness 171 171
Bruise/Contusion 162 162
Malaise 161 161
Muscle Weakness 160 160
Fluid Discharge 158 158
Burn(s) 149 149
Swelling/ Edema 144 144
Blurred Vision 141 141
Polydipsia 130 130
Skin Inflammation 117 117
Discomfort 117 117
Burning Sensation 111 111
Hypersensitivity/Allergic reaction 98 98
Device Embedded In Tissue or Plaque 95 95
Hemorrhage/Bleeding 89 89
Abscess 88 88
Inflammation 85 85
Coma 64 64
Fall 58 58
Dehydration 55 55
Lethargy 55 55
Fever 45 45
Tachycardia 43 43
Fainting 37 37
Abdominal Pain 36 36
Electric Shock 36 36
Foreign Body In Patient 30 30
Chills 30 30
Infection, Pyrogenic 26 26
Numbness 21 21
Cramp(s) /Muscle Spasm(s) 21 21
No Code Available 21 21
Skin Burning Sensation 20 20
Caustic/Chemical Burns 20 20
Tingling 20 20
Hot Flashes/Flushes 19 19
Urinary Frequency 18 18
Hematoma 18 18
Scarring 18 18
Cellulitis 16 16
Blister 16 16
Cognitive Changes 15 15
Palpitations 14 14
Skin Discoloration 14 14
Anxiety 13 13
Peeling 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Diarrhea 12 12
Chest Pain 11 11
Vertigo 11 11
Discharge 11 11
Balance Problems 11 11
Pallor 10 10
Dyspnea 10 10
Edema 10 10
No Consequences Or Impact To Patient 9 9
Visual Impairment 9 9
Blood Loss 8 8
Local Reaction 8 8
Shock from Patient Lead(s) 7 7
Paralysis 6 6
Skin Tears 6 6
Fungal Infection 6 6
Skin Erosion 6 6
Cramp(s) 6 6
Loss of Vision 5 5
High Blood Pressure/ Hypertension 5 5
Bacterial Infection 4 4
Sepsis 4 4
Irritation 4 4
Urticaria 4 4

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