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 electrode, ion based, enzymatic, creatinine
Product CodeCGL
Regulation Number 862.1225
Device Class 2

MDR Year MDR Reports MDR Events
2018 11 11
2019 25 25
2020 19 19
2021 20 20
2022 11 11
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 36 36
Non Reproducible Results 21 21
Incorrect Measurement 13 13
Low Test Results 10 10
Low Readings 3 3
High Test Results 3 3
Erratic Results 3 3
Insufficient Information 3 3
Defective Component 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Fluid/Blood Leak 1 1
Smoking 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 28
No Consequences Or Impact To Patient 16 16
No Information 10 10
No Known Impact Or Consequence To Patient 9 9
Insufficient Information 9 9
No Code Available 3 3
Cancer 3 3
Hematuria 2 2
Abnormal Blood Gases 2 2
Abdominal Pain 2 2
Apnea 1 1
Breast Cancer 1 1
Cardiac Arrest 1 1
Death 1 1
Pain 1 1
Peripheral Vascular Disease 1 1
Transient Ischemic Attack 1 1
No Patient Involvement 1 1
Premature Labor 1 1
Sudden Cardiac Death 1 1
Claudication 1 1

-
-