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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems
Definition An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.
Product CodeQLG
Regulation Number 862.1355
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT DIABETES CARE INC.
  SUBSTANTIALLY EQUIVALENT 6
ABBOTT DIABETES CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIGFOOT BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 1069 1069
2021 22500 22500
2022 26532 26532
2023 27130 27130

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 50784 50784
Unable to Obtain Readings 11613 11613
Device Displays Incorrect Message 11141 11141
Detachment of Device or Device Component 3074 3074
Product Quality Problem 2733 2733
High Readings 2419 2419
Device Alarm System 2165 2165
Low Readings 1936 1936
Adverse Event Without Identified Device or Use Problem 1452 1452
Failure to Power Up 613 613
Application Program Problem 235 235
Premature Discharge of Battery 131 131
No Audible Alarm 130 130
Failure to Fire 76 76
Material Twisted/Bent 71 71
No Device Output 69 69
Appropriate Term/Code Not Available 65 65
Difficult to Insert 61 61
Power Problem 51 51
Display or Visual Feedback Problem 38 38
Unintended Electrical Shock 33 33
Battery Problem 32 32
Key or Button Unresponsive/not Working 29 29
Insufficient Information 25 25
No Display/Image 19 19
Component Missing 18 18
Data Problem 16 16
Failure to Charge 14 14
Device Damaged Prior to Use 12 12
Defective Device 11 11
Therapeutic or Diagnostic Output Failure 11 11
Packaging Problem 11 11
Break 10 10
Use of Device Problem 9 9
Compatibility Problem 9 9
Shipping Damage or Problem 8 8
Activation, Positioning or Separation Problem 8 8
Erratic or Intermittent Display 7 7
Output Problem 7 7
No Apparent Adverse Event 6 6
Application Program Freezes, Becomes Nonfunctional 6 6
Crack 6 6
Computer Software Problem 5 5
Image Display Error/Artifact 5 5
Firing Problem 5 5
Patient Device Interaction Problem 4 4
Mechanical Problem 4 4
Defective Alarm 4 4
Device Sensing Problem 4 4
Device-Device Incompatibility 4 4
Charging Problem 4 4
Application Program Version or Upgrade Problem 4 4
No Audible Prompt/Feedback 4 4
Defective Component 4 4
Material Separation 4 4
Failure to Deliver 3 3
Loss of or Failure to Bond 3 3
Display Difficult to Read 3 3
Explosion 3 3
Activation Failure 3 3
Audible Prompt/Feedback Problem 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Material Deformation 2 2
Protective Measures Problem 2 2
Activation Problem 2 2
Unexpected Shutdown 2 2
False Alarm 2 2
Delayed Alarm 2 2
Nonstandard Device 2 2
Device Difficult to Setup or Prepare 2 2
Low Test Results 2 2
Inaudible or Unclear Audible Prompt/Feedback 2 2
Communication or Transmission Problem 2 2
Component or Accessory Incompatibility 2 2
Connection Problem 1 1
Failure to Obtain Sample 1 1
Difficult or Delayed Activation 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Smoking 1 1
Intermittent Infusion 1 1
High Test Results 1 1
Premature End-of-Life Indicator 1 1
Retraction Problem 1 1
Self-Activation or Keying 1 1
Sensing Intermittently 1 1
Failure to Sense 1 1
Failure to Run on Battery 1 1
Electromagnetic Interference 1 1
Fire 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Accessory Incompatible 1 1
Unintended Power Up 1 1
Failure to Discharge 1 1
Sharp Edges 1 1
Device Fell 1 1
Problem with Software Installation 1 1
Missing Test Results 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 53118 53118
Hypoglycemia 13828 13828
Loss of consciousness 10446 10446
Convulsion/Seizure 4356 4356
Diaphoresis 2556 2556
Hyperglycemia 2428 2428
Dizziness 2112 2112
Insufficient Information 1763 1763
Shaking/Tremors 1606 1606
Confusion/ Disorientation 922 922
Fatigue 888 888
Skin Infection 752 752
Skin Inflammation/ Irritation 562 562
Pain 540 540
No Known Impact Or Consequence To Patient 507 507
Headache 504 504
Nausea 367 367
Vomiting 351 351
Blurred Vision 339 339
Erythema 260 260
Muscle Weakness 257 257
Hypersensitivity/Allergic reaction 225 225
Diabetic Ketoacidosis 202 202
Itching Sensation 183 183
Swelling/ Edema 179 179
Hemorrhage/Bleeding 168 168
Malaise 143 143
Discomfort 128 128
Fall 125 125
Purulent Discharge 123 123
Polydipsia 103 103
Cramp(s) /Muscle Spasm(s) 78 78
Device Embedded In Tissue or Plaque 77 77
Tachycardia 76 76
Abscess 75 75
Chills 72 72
Bruise/Contusion 67 67
Hot Flashes/Flushes 66 66
Cognitive Changes 64 64
Sweating 61 61
Lethargy 57 57
Seizures 49 49
Electric Shock 45 45
Coma 31 31
Rash 29 29
Unspecified Infection 29 29
Blister 28 28
Balance Problems 26 26
Burning Sensation 26 26
Skin Irritation 23 23
Dehydration 20 20
Numbness 15 15
Fever 14 14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 14 14
Fluid Discharge 14 14
Skin Inflammation 12 12
Undesired Nerve Stimulation 11 11
Foreign Body In Patient 11 11
No Information 11 11
Hematoma 10 10
Swelling 9 9
Burn(s) 7 7
Skin Burning Sensation 6 6
Shock from Patient Lead(s) 5 5
Neuropathy 5 5
Palpitations 5 5
Pallor 4 4
Weakness 4 4
Urinary Frequency 4 4
Skin Discoloration 4 4
Decreased Appetite 4 4
Hypoglycemic Shock 3 3
Contact Dermatitis 3 3
Superficial (First Degree) Burn 3 3
Sepsis 3 3
Inflammation 3 3
Abdominal Pain 3 3
Cramp(s) 3 3
Anxiety 2 2
Fainting 2 2
No Code Available 2 2
Localized Skin Lesion 1 1
Aphonia 1 1
Unspecified Heart Problem 1 1
Unspecified Ear or Labyrinth Problem 1 1
Subcutaneous Nodule 1 1
Increased Appetite 1 1
Chest Pain 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1
Discharge 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Tingling 1 1
Collapse 1 1
Post Traumatic Wound Infection 1 1
Needle Stick/Puncture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Aug-17-2023
2 Abbott Diabetes Care, Inc. I Apr-06-2023
3 Cardinal Health Inc. II Jun-23-2021
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