• 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 glucose dehydrogenase, glucose
Regulation Description Glucose test system.
Product CodeLFR
Regulation Number 862.1345
Device Class 2

MDR Year MDR Reports MDR Events
2020 132 132
2021 164 164
2022 101 101
2023 103 103
2024 172 172
2025 374 374

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 332 332
Erratic Results 247 247
Incorrect, Inadequate or Imprecise Result or Readings 208 208
Non Reproducible Results 121 121
Low Test Results 108 108
Material Twisted/Bent 7 7
Incorrect Measurement 6 6
Device Sensing Problem 5 5
Unintended Movement 5 5
Component Missing 5 5
Inaccurate Information 4 4
Labelling, Instructions for Use or Training Problem 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Loss of or Failure to Bond 3 3
Device Displays Incorrect Message 3 3
No Apparent Adverse Event 3 3
Shipping Damage or Problem 3 3
Contamination /Decontamination Problem 3 3
Defective Device 3 3
Insufficient Information 3 3
Output Problem 3 3
Circuit Failure 3 3
Failure to Power Up 2 2
Use of Device Problem 2 2
Material Integrity Problem 2 2
Failure to Fire 2 2
Display Difficult to Read 2 2
Illegible Information 2 2
Display or Visual Feedback Problem 2 2
Incomplete or Missing Packaging 2 2
Activation, Positioning or Separation Problem 2 2
High Readings 1 1
Defective Component 1 1
Imprecision 1 1
Failure to Sense 1 1
Application Program Problem: Dose Calculation Error 1 1
Device Difficult to Program or Calibrate 1 1
Calibration Problem 1 1
Device Markings/Labelling Problem 1 1
Image Display Error/Artifact 1 1
Communication or Transmission Problem 1 1
Product Quality Problem 1 1
Low Readings 1 1
Appropriate Term/Code Not Available 1 1
No Device Output 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 770 770
No Consequences Or Impact To Patient 167 167
Hyperglycemia 41 41
Hypoglycemia 37 37
Insufficient Information 9 9
Loss of consciousness 9 9
Shaking/Tremors 6 6
Diabetic Ketoacidosis 5 5
Dizziness 3 3
Vomiting 3 3
Coma 3 3
Fatigue 2 2
No Known Impact Or Consequence To Patient 2 2
Abdominal Pain 1 1
Syncope/Fainting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Skin Irritation 1 1
Diaphoresis 1 1
Confusion/ Disorientation 1 1
Numbness 1 1
Tachycardia 1 1
Aphonia 1 1
Headache 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Roche Diabetes Care, Inc. II Aug-26-2021
-
-