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
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)
2019 2020 2021 2022 2023 2024 2025 2026
1 0 0 0 0 2 0 0

MDR Year MDR Reports MDR Events
2019 44510 44512
2020 10579 10584
2021 4943 4945
2022 1378 1383
2023 6373 6382
2024 22389 22394
2025 38635 38645
2026 5812 5812

Device Problems MDRs with this Device Problem Events in those MDRs
Wireless Communication Problem 87176 87192
No Device Output 24053 24053
Communication or Transmission Problem 4087 4092
Imprecision 3905 3905
Display or Visual Feedback Problem 3583 3583
Premature End-of-Life Indicator 3515 3515
Incorrect, Inadequate or Imprecise Result or Readings 2777 2777
Battery Problem 2312 2313
Detachment of Device or Device Component 2146 2148
Unable to Obtain Readings 2115 2115
Unexpected Shutdown 1847 1847
Calibration Problem 1762 1762
Appropriate Term/Code Not Available 1741 1742
Connection Problem 1163 1163
Unintended Application Program Shut Down 1096 1096
Defective Alarm 968 968
Inappropriate or Unexpected Reset 804 804
Break 645 646
Device Displays Incorrect Message 611 611
No Audible Alarm 378 378
Unexpected Therapeutic Results 235 235
Retraction Problem 205 205
Computer Software Problem 169 169
Adverse Event Without Identified Device or Use Problem 149 151
Overheating of Device 107 107
Low Audible Alarm 87 87
Application Program Freezes, Becomes Nonfunctional 85 85
Moisture or Humidity Problem 83 83
Alarm Not Visible 80 80
Material Integrity Problem 62 62
Failure of Device to Self-Test 59 59
Delayed Alarm 59 69
Operating System Version or Upgrade Problem 40 40
Material Twisted/Bent 37 37
Activation Problem 37 37
Use of Device Problem 31 31
Delivered as Unsterile Product 21 21
Loss of or Failure to Bond 20 20
Device Difficult to Program or Calibrate 17 17
Packaging Problem 17 17
Device Alarm System 16 16
Insufficient Information 15 15
Manufacturing, Packaging or Shipping Problem 13 13
Output Problem 11 11
Failure to Fire 11 11
Patient Device Interaction Problem 10 10
Unauthorized Access to Computer System 10 10
Difficult to Remove 9 9
Obstruction of Flow 9 9
Application Network Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 75919 75946
No Consequences Or Impact To Patient 54309 54309
Hemorrhage/Bleeding 1645 1645
Hyperglycemia 1545 1547
Hypoglycemia 948 948
Loss of consciousness 176 176
Diabetic Ketoacidosis 101 101
Pain 91 93
Skin Inflammation/ Irritation 66 66
Reaction 63 63
Vomiting 54 56
Erythema 53 53
Malaise 42 42
Bruise/Contusion 41 41
Foreign Body In Patient 38 39
No Known Impact Or Consequence To Patient 36 39
Confusion/ Disorientation 36 36
Itching Sensation 34 36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Insufficient Information 33 33
Discomfort 29 29
Nausea 24 24
Fatigue 23 23
Rash 22 24
Dizziness 22 22
Diaphoresis 20 20
Sweating 19 19
Fall 19 19
Unspecified Infection 19 19
Seizures 18 18
Skin Irritation 16 16
Needle Stick/Puncture 16 16
Headache 15 15
Purulent Discharge 15 15
Blood Loss 15 15
Shaking/Tremors 11 11
Hematoma 10 10
Injury 10 10
Swelling 9 9
Hypersensitivity/Allergic reaction 9 9
Weakness 9 9
Scarring 9 11
Collapse 7 7
Burning Sensation 7 9
Skin Infection 7 7
Blurred Vision 6 6
Polydipsia 6 6
Coma 6 6
Skin Inflammation 5 5
Chest Pain 5 5

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
-
-