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TPLC
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Device
equipment, laboratory, general purpose, labeled or promoted for a specific medical use
Product Code
LXG
Regulation Number
862.2050
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
25
25
2019
27
27
2020
14
14
2021
11
11
2022
13
13
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
9
9
Break
8
8
Overheating of Device
6
6
Use of Device Problem
5
5
Unintended Movement
5
5
Appropriate Term/Code Not Available
5
5
Patient Data Problem
5
5
Non Reproducible Results
4
4
Leak/Splash
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Thermal Decomposition of Device
4
4
Electrical /Electronic Property Problem
3
3
Device Displays Incorrect Message
3
3
Device Operates Differently Than Expected
3
3
Communication or Transmission Problem
2
2
Defective Device
2
2
Labelling, Instructions for Use or Training Problem
2
2
Detachment Of Device Component
2
2
Self-Activation or Keying
2
2
Problem with Software Installation
2
2
Protective Measures Problem
1
1
Temperature Problem
1
1
Device Handling Problem
1
1
Missing Test Results
1
1
Physical Resistance/Sticking
1
1
Device Remains Activated
1
1
Delivered as Unsterile Product
1
1
Device Emits Odor
1
1
Unintended System Motion
1
1
Corroded
1
1
Crack
1
1
Device Reprocessing Problem
1
1
Defective Alarm
1
1
Fluid/Blood Leak
1
1
Improper or Incorrect Procedure or Method
1
1
Detachment of Device or Device Component
1
1
Device Markings/Labelling Problem
1
1
Sparking
1
1
Chemical Problem
1
1
Difficult to Open or Close
1
1
Failure to Auto Stop
1
1
Device Contamination with Chemical or Other Material
1
1
Installation-Related Problem
1
1
Mechanics Altered
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Power Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
37
37
No Clinical Signs, Symptoms or Conditions
24
24
No Consequences Or Impact To Patient
16
16
No Patient Involvement
8
8
No Information
3
3
Insufficient Information
2
2
Test Result
1
1
Burn(s)
1
1
Death
1
1
Hypersensitivity/Allergic reaction
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomedical Polymers, Inc.
III
Nov-05-2019
2
Dynex Technologies, Inc.
II
Jun-02-2022
3
Siemens Healthcare Diagnostics, Inc.
II
Oct-23-2018
4
Sysmex America, Inc.
II
Apr-14-2020
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