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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 26539 26539
2023 39511 39511
2024 7147 7147

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 63822 63822
Unable to Obtain Readings 13896 13896
Device Displays Incorrect Message 13613 13613
Detachment of Device or Device Component 3571 3571
High Readings 3335 3335
Product Quality Problem 3289 3289
Low Readings 2653 2653
Device Alarm System 2635 2635
Adverse Event Without Identified Device or Use Problem 1849 1849
Failure to Power Up 757 757
Application Program Problem 319 319
Premature Discharge of Battery 183 183
No Audible Alarm 130 130
Failure to Fire 109 109
Material Twisted/Bent 89 89
No Device Output 88 88
Power Problem 69 69
Unintended Electrical Shock 69 69
Appropriate Term/Code Not Available 65 65
Difficult to Insert 63 63
Display or Visual Feedback Problem 51 51
Battery Problem 37 37
Key or Button Unresponsive/not Working 37 37
Insufficient Information 29 29
No Display/Image 20 20
Component Missing 19 19
Activation, Positioning or Separation Problem 18 18
Data Problem 16 16
Failure to Charge 14 14
Device Damaged Prior to Use 13 13
Packaging Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Defective Device 11 11
Break 11 11
Use of Device Problem 9 9
Compatibility Problem 9 9
No Apparent Adverse Event 8 8
Application Program Freezes, Becomes Nonfunctional 8 8
Shipping Damage or Problem 8 8
Computer Software Problem 8 8
Erratic or Intermittent Display 7 7
Output Problem 7 7
Crack 6 6
No Audible Prompt/Feedback 6 6
Charging Problem 5 5
Device Sensing Problem 5 5
Image Display Error/Artifact 5 5
Audible Prompt/Feedback Problem 5 5
Patient Device Interaction Problem 5 5
Firing Problem 5 5
Mechanical Problem 4 4
Defective Alarm 4 4
Loss of or Failure to Bond 4 4
Device-Device Incompatibility 4 4
Communication or Transmission Problem 4 4
Application Program Version or Upgrade Problem 4 4
Defective Component 4 4
Material Separation 4 4
Failure to Deliver 3 3
Display Difficult to Read 3 3
Explosion 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Activation Failure 3 3
Activation Problem 2 2
Material Deformation 2 2
Material Protrusion/Extrusion 2 2
Operating System Version or Upgrade Problem 2 2
Unexpected Shutdown 2 2
No Visual Prompts/Feedback 2 2
Protective Measures Problem 2 2
False Alarm 2 2
Delayed Alarm 2 2
Nonstandard Device 2 2
Failure to Run on Battery 2 2
Device Difficult to Setup or Prepare 2 2
Low Test Results 2 2
Inaudible or Unclear Audible Prompt/Feedback 2 2
Self-Activation or Keying 2 2
Failure to Obtain Sample 2 2
Difficult or Delayed Activation 2 2
Component or Accessory Incompatibility 2 2
Difficult to Open or Remove Packaging Material 2 2
Connection Problem 1 1
Loss of Data 1 1
Date/Time-Related Software Problem 1 1
Sensing Intermittently 1 1
Failure to Sense 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
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 66882 66882
Hypoglycemia 17227 17227
Loss of consciousness 13065 13065
Convulsion/Seizure 5251 5251
Diaphoresis 3266 3266
Hyperglycemia 3174 3174
Dizziness 2696 2696
Insufficient Information 2080 2080
Shaking/Tremors 2071 2071
Fatigue 1331 1331
Confusion/ Disorientation 1186 1186
Skin Infection 986 986
Pain 715 715
Skin Inflammation/ Irritation 688 688
Headache 653 653
No Known Impact Or Consequence To Patient 507 507
Nausea 496 496
Blurred Vision 460 460
Vomiting 454 454
Erythema 327 327
Hypersensitivity/Allergic reaction 314 314
Muscle Weakness 257 257
Diabetic Ketoacidosis 256 256
Swelling/ Edema 243 243
Itching Sensation 218 218
Hemorrhage/Bleeding 209 209
Discomfort 183 183
Purulent Discharge 152 152
Malaise 143 143
Polydipsia 132 132
Fall 125 125
Tachycardia 114 114
Cognitive Changes 107 107
Abscess 95 95
Bruise/Contusion 88 88
Device Embedded In Tissue or Plaque 87 87
Hot Flashes/Flushes 83 83
Cramp(s) /Muscle Spasm(s) 78 78
Chills 72 72
Sweating 61 61
Lethargy 57 57
Rash 50 50
Seizures 49 49
Electric Shock 45 45
Dehydration 44 44
Coma 43 43
Numbness 34 34
Blister 34 34
Unspecified Infection 30 30
Fever 29 29
Burning Sensation 28 28
Balance Problems 26 26
Skin Irritation 23 23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Fluid Discharge 17 17
Foreign Body In Patient 13 13
Hematoma 12 12
Skin Inflammation 12 12
Undesired Nerve Stimulation 11 11
Neuropathy 11 11
No Information 11 11
Skin Discoloration 10 10
Swelling 9 9
Burn(s) 7 7
Hypoglycemic Shock 6 6
Decreased Appetite 6 6
Skin Burning Sensation 6 6
Shock from Patient Lead(s) 5 5
Increased Appetite 5 5
Palpitations 5 5
Pallor 4 4
Needle Stick/Puncture 4 4
Weakness 4 4
Urinary Frequency 4 4
Cramp(s) 3 3
Abdominal Pain 3 3
Sepsis 3 3
Inflammation 3 3
Contact Dermatitis 3 3
Superficial (First Degree) Burn 3 3
No Code Available 2 2
Unspecified Heart Problem 2 2
Fainting 2 2
Anxiety 2 2
Discharge 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Tingling 1 1
Caustic/Chemical Burns 1 1
Post Traumatic Wound Infection 1 1
Collapse 1 1
Impaired Healing 1 1
Chest Pain 1 1
Muscle Spasm(s) 1 1
Myocardial Infarction 1 1
Unspecified Ear or Labyrinth Problem 1 1
Dry Mouth 1 1
Localized Skin Lesion 1 1
Subcutaneous Nodule 1 1
Cancer 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Diabetes Care, Inc. II Jan-16-2024
2 Abbott Diabetes Care, Inc. II Aug-17-2023
3 Abbott Diabetes Care, Inc. I Apr-06-2023
4 Cardinal Health Inc. II Jun-23-2021
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