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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device instrument, coagulation, automated
Product CodeGKP
Regulation Number 864.5400
Device Class 2

MDR Year MDR Reports MDR Events
2017 18 18
2018 19 19
2019 38 38
2020 14 14
2021 17 17
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 34 34
Adverse Event Without Identified Device or Use Problem 23 23
High Test Results 12 12
Low Test Results 12 12
Use of Device Problem 8 8
Incorrect Or Inadequate Test Results 5 5
Mechanical Problem 3 3
Contamination /Decontamination Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Data Problem 2 2
Device Handling Problem 1 1
Insufficient Information 1 1
Smoking 1 1
Computer Software Problem 1 1
Electrical /Electronic Property Problem 1 1
Fire 1 1
Flushing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 71 71
No Clinical Signs, Symptoms or Conditions 24 24
Therapeutic Response, Increased 10 10
Needle Stick/Puncture 3 3
Abrasion 1 1
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Instrumentation Laboratory II Apr-28-2022
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