• 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
Definition A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.
Product CodePQF
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 2 0

MDR Year MDR Reports MDR Events
2020 10579 10579
2021 4943 4943
2022 1378 1378
2023 6374 6374
2024 22388 22391
2025 3303 3313

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 34481 34484
No Device Output 9303 9303
Communication or Transmission Problem 4060 4060
Display or Visual Feedback Problem 1773 1773
Appropriate Term/Code Not Available 1395 1395
Battery Problem 1003 1003
Calibration Problem 976 976
Incorrect, Inadequate or Imprecise Result or Readings 899 899
Unintended Application Program Shut Down 820 820
Connection Problem 652 652
Imprecision 521 521
Premature End-of-Life Indicator 390 390
Detachment of Device or Device Component 351 351
Unable to Obtain Readings 267 267
Break 248 248
Unexpected Shutdown 217 217
Inappropriate or Unexpected Reset 127 127
Defective Alarm 111 111
Computer Software Problem 95 95
Unexpected Therapeutic Results 59 59
Failure of Device to Self-Test 59 59
Delayed Alarm 58 68
Moisture or Humidity Problem 55 55
No Audible Alarm 39 39
Operating System Version or Upgrade Problem 36 36
Use of Device Problem 29 29
Adverse Event Without Identified Device or Use Problem 19 19
Alarm Not Visible 17 17
Application Program Freezes, Becomes Nonfunctional 15 15
Patient Device Interaction Problem 10 10
Overheating of Device 10 10
Low Audible Alarm 10 10
Obstruction of Flow 8 8
Activation Problem 8 8
Manufacturing, Packaging or Shipping Problem 6 6
Delivered as Unsterile Product 6 6
Application Network Problem 5 5
Packaging Problem 5 5
Unauthorized Access to Computer System 5 5
Insufficient Information 4 4
Failure to Sense 3 3
Device Alarm System 3 3
Material Twisted/Bent 3 3
Fracture 3 3
Therapeutic or Diagnostic Output Failure 2 2
Failure to Fire 2 2
Arcing at Paddles 2 2
Output Problem 2 2
Environmental Compatibility Problem 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 37284 37297
No Consequences Or Impact To Patient 10259 10259
Hemorrhage/Bleeding 611 611
Hyperglycemia 518 518
Hypoglycemia 261 261
Diabetic Ketoacidosis 40 40
Loss of consciousness 31 31
Pain 28 28
Discomfort 23 23
Skin Inflammation/ Irritation 19 19
Vomiting 19 19
Foreign Body In Patient 16 16
Bruise/Contusion 13 13
No Known Impact Or Consequence To Patient 12 12
Fatigue 12 12
Insufficient Information 11 11
Malaise 8 8
Nausea 8 8
Reaction 7 7
Confusion/ Disorientation 7 7
Erythema 7 7
Itching Sensation 7 7
Hematoma 6 6
Rash 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Headache 5 5
Polydipsia 5 5
Dizziness 5 5
Fall 5 5
Cardiac Arrest 4 4
Hypersensitivity/Allergic reaction 4 4
Coma 3 3
Convulsion/Seizure 3 3
Shaking/Tremors 3 3
Electrolyte Imbalance 3 3
Myocardial Infarction 2 2
Sleep Dysfunction 2 2
Diaphoresis 2 2
Unspecified Infection 2 2
Skin Infection 2 2
Sweating 2 2
Sore Throat 2 2
Skin Irritation 2 2
Head Injury 2 2
Lethargy 2 2
Burning Sensation 2 2
Hypoglycemic Shock 2 2
Scarring 2 2
Pressure Sores 2 2
Muscle Weakness 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Dexcom Inc II Mar-25-2020
2 Tandem Diabetes Care Inc II Sep-26-2022
3 Tandem Diabetes Care Inc II Jun-10-2022
-
-