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 1904 1904

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 91888 91888
Appropriate Term/Code Not Available 4085 4085
Device Displays Incorrect Message 3705 3705
Unable to Obtain Readings 3399 3399
High Readings 3108 3108
Low Readings 2393 2393
Detachment of Device or Device Component 1153 1153
Application Program Problem 1035 1035
Adverse Event Without Identified Device or Use Problem 970 970
Product Quality Problem 916 916
Device Alarm System 424 424
Failure to Power Up 290 290
No Device Output 112 112
Material Twisted/Bent 51 51
Failure to Fire 48 48
Difficult to Insert 42 42
Insufficient Information 39 39
Premature Discharge of Battery 37 37
Computer Software Problem 32 32
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
Therapeutic or Diagnostic Output Failure 15 15
Key or Button Unresponsive/not Working 15 15
Application Program Version or Upgrade Problem 15 15
Patient-Device Incompatibility 15 15
Unintended Electrical Shock 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
Device Fell 6 6
Activation Failure 6 6
Patient Device Interaction Problem 6 6
Firing Problem 5 5
Connection Problem 5 5
Device Sensing Problem 5 5
Compatibility Problem 5 5
Failure to Discharge 5 5
Display Difficult to Read 5 5
Erratic or Intermittent Display 5 5
Fire 5 5
Device Damaged Prior to Use 5 5
Misfire 5 5
Failure to Deliver 4 4
Defective Component 4 4
Use of Device Problem 4 4
Material Separation 4 4
Mechanical Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
No Apparent Adverse Event 4 4
Missing Test Results 4 4
Protective Measures Problem 4 4
Device-Device Incompatibility 3 3
Loss of Data 3 3
Labelling, Instructions for Use or Training Problem 3 3
Image Display Error/Artifact 3 3
Loss of or Failure to Bond 3 3
Failure to Run on Battery 3 3
Failure to Sense 3 3
Device Slipped 3 3
Low Test Results 3 3
Difficult or Delayed Activation 3 3
Premature End-of-Life Indicator 2 2
Nonstandard Device 2 2
Charging Problem 2 2
Material Protrusion/Extrusion 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
Device Markings/Labelling Problem 1 1
Device Operates Differently Than Expected 1 1
Activation, Positioning or Separation Problem 1 1
Delivered as Unsterile Product 1 1
Unsealed Device Packaging 1 1
Incorrect Measurement 1 1
Melted 1 1
Unintended Power Up 1 1
Detachment Of Device Component 1 1
Use of Incorrect Control/Treatment Settings 1 1
Thermal Decomposition of Device 1 1
Burst Container or Vessel 1 1
Bent 1 1
Accessory Incompatible 1 1
Delayed Alarm 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89198 89198
Hypoglycemia 5720 5720
No Known Impact Or Consequence To Patient 4503 4503
Loss of consciousness 4361 4361
Skin Irritation 2835 2835
Hyperglycemia 2461 2461
Itching Sensation 1549 1549
Erythema 1483 1483
Unspecified Infection 1250 1250
Convulsion/Seizure 1063 1063
Dizziness 1005 1005
Insufficient Information 862 862
Pain 859 859
Shaking/Tremors 738 738
Diaphoresis 704 704
Skin Infection 528 528
Diabetic Ketoacidosis 451 451
Purulent Discharge 421 421
Vomiting 416 416
Skin Inflammation/ Irritation 415 415
Sweating 385 385
Confusion/ Disorientation 372 372
Fatigue 370 370
Headache 350 350
Rash 345 345
Nausea 296 296
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 148 148
Blurred Vision 144 144
Polydipsia 131 131
Skin Inflammation 117 117
Discomfort 117 117
Burning Sensation 112 112
Hypersensitivity/Allergic reaction 99 99
Device Embedded In Tissue or Plaque 95 95
Hemorrhage/Bleeding 91 91
Abscess 89 89
Inflammation 85 85
Coma 64 64
Fall 58 58
Dehydration 55 55
Lethargy 55 55
Fever 45 45
Tachycardia 44 44
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
Cognitive Changes 18 18
Hematoma 18 18
Scarring 18 18
Cellulitis 16 16
Blister 16 16
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
-
-