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 continuous glucose monitor, implanted, adjunctive use
Definition The device is a fully implanted continuous glucose monitoring device intended to detect trends and track patterns in interstitial glucose values. The device is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
Product CodeQCD
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022 2023 2024
0 5 4 0 0 0 1 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 270 270
2020 576 576
2021 157 157
2022 29 29
2023 115 115
2024 364 364

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 449 449
Failure to Sense 411 411
Adverse Event Without Identified Device or Use Problem 329 329
Difficult to Remove 157 157
Device Sensing Problem 34 34
Device Alarm System 28 28
Material Separation 28 28
Insufficient Information 14 14
Electrical /Electronic Property Problem 11 11
Communication or Transmission Problem 10 10
Connection Problem 10 10
Overheating of Device 9 9
Intermittent Communication Failure 5 5
Calibration Problem 4 4
Device Appears to Trigger Rejection 4 4
No Apparent Adverse Event 3 3
Temperature Problem 3 3
Malposition of Device 2 2
Use of Device Problem 2 2
Installation-Related Problem 2 2
Appropriate Term/Code Not Available 2 2
Inaccurate Information 2 2
Failure to Charge 1 1
Activation, Positioning or Separation Problem 1 1
Off-Label Use 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Device Fell 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Battery Problem 1 1
Charging Problem 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Low Audible Alarm 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Excessive Heating 1 1
Premature Discharge of Battery 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypoglycemia 338 338
No Clinical Signs, Symptoms or Conditions 270 270
No Known Impact Or Consequence To Patient 237 237
Discomfort 216 216
No Code Available 171 171
Hyperglycemia 122 122
Skin Infection 62 62
Unspecified Infection 46 46
Pain 46 46
Abscess 30 30
Post Operative Wound Infection 26 26
Skin Inflammation/ Irritation 23 23
Swelling/ Edema 17 17
Diabetic Ketoacidosis 10 10
Fluid Discharge 9 9
Hemorrhage/Bleeding 9 9
Inflammation 8 8
No Information 7 7
Itching Sensation 7 7
No Consequences Or Impact To Patient 7 7
Implant Pain 6 6
Wound Dehiscence 5 5
Nausea 5 5
Dizziness 5 5
Insufficient Information 4 4
Numbness 3 3
Rash 3 3
Blood Loss 3 3
Cellulitis 3 3
Easy Bruising 2 2
Local Reaction 2 2
Hematoma 2 2
Bone Fracture(s) 2 2
Skin Irritation 2 2
Encephalopathy 2 2
Bacterial Infection 1 1
Headache 1 1
Convulsion/Seizure 1 1
Loss of consciousness 1 1
Hypoglycemic Shock 1 1
Nodule 1 1
Shaking/Tremors 1 1
Anxiety 1 1
Undesired Nerve Stimulation 1 1
Fibrosis 1 1
Heart Failure/Congestive Heart Failure 1 1
Missing Value Reason 1 1
Pneumonia 1 1
Subcutaneous Nodule 1 1
Vertebral Fracture 1 1

-
-