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TPLC
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show TPLC since
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Device
instrument, coagulation, automated
Product Code
GKP
Regulation Number
864.5400
Device Class
2
Premarket Reviews
Manufacturer
Decision
INSTRUMENTATION LABORATORY (IL) CO.
SUBSTANTIALLY EQUIVALENT
1
INSTRUMENTATION LABORATORY CO.
SUBSTANTIALLY EQUIVALENT
3
INSTRUMENTATION LABORATORY COMPANY
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
26
26
2015
24
24
2016
13
13
2017
18
18
2018
19
19
2019
38
38
2020
14
14
2021
17
17
2022
4
4
2023
4
4
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
41
41
Adverse Event Without Identified Device or Use Problem
36
36
High Test Results
23
23
Low Test Results
22
22
Incorrect Or Inadequate Test Results
12
12
Use of Device Problem
11
11
Data Problem
5
5
Device Displays Incorrect Message
5
5
Improper or Incorrect Procedure or Method
5
5
Smoking
4
4
Device Operates Differently Than Expected
4
4
Patient Data Problem
3
3
Device Handling Problem
3
3
Insufficient Information
3
3
Contamination /Decontamination Problem
3
3
Mechanical Problem
3
3
Fluid/Blood Leak
3
3
Temperature Problem
3
3
Fail-Safe Problem
2
2
False Positive Result
2
2
Fire
2
2
Melted
2
2
Electrical /Electronic Property Problem
1
1
Component Missing
1
1
Computer Software Problem
1
1
Flushing Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
102
102
No Clinical Signs, Symptoms or Conditions
27
27
Therapeutic Response, Increased
10
10
Needle Stick/Puncture
9
9
No Code Available
7
7
Misdiagnosis
7
7
No Consequences Or Impact To Patient
6
6
Venipuncture
3
3
No Information
3
3
Death
2
2
Test Result
2
2
Abrasion
2
2
Emotional Changes
1
1
Missed Dose
1
1
Overdose
1
1
Injury
1
1
Exposure to Body Fluids
1
1
Eye Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Instrumentation Laboratory
II
Sep-12-2023
2
Instrumentation Laboratory
II
Apr-28-2022
3
Instrumentation Laboratory Co.
II
Jul-16-2014
4
Instrumentation Laboratory Co.
II
Sep-18-2013
5
Instrumentation Laboratory Co.
II
Sep-14-2012
6
Instrumentation Laboratory Co.
II
Oct-25-2010
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