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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
blood grouping reagent
Definition
For red blood cell antigen typing
Product Code
QHR
Regulation Number
660.20
Device Class
Unclassified
MDR Year
MDR Reports
MDR Events
2019
17
17
2020
84
84
2021
90
90
2022
64
64
2023
82
82
2024
39
39
Device Problems
MDRs with this Device Problem
Events in those MDRs
False Positive Result
196
196
False Negative Result
72
72
Adverse Event Without Identified Device or Use Problem
52
52
Incorrect, Inadequate or Imprecise Result or Readings
35
35
Improper or Incorrect Procedure or Method
14
14
Output Problem
13
13
No Apparent Adverse Event
10
10
Defective Device
8
8
Defective Component
4
4
Off-Label Use
2
2
Incorrect Measurement
2
2
Patient Device Interaction Problem
2
2
Device Damaged Prior to Use
1
1
Short Fill
1
1
Component Missing
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
344
344
No Known Impact Or Consequence To Patient
47
47
Insufficient Information
4
4
No Consequences Or Impact To Patient
4
4
Reaction
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Test Result
2
2
Hemolysis
1
1
Laceration(s)
1
1
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