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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


Premarket Reviews
ManufacturerDecision
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

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
Improper or Incorrect Procedure or Method 5 5
Device Displays Incorrect Message 5 5
Data Problem 5 5
Device Operates Differently Than Expected 4 4
Temperature Problem 3 3
Insufficient Information 3 3
Patient Data Problem 3 3
Device Handling Problem 3 3
Contamination /Decontamination Problem 3 3
Smoking 3 3
Fluid/Blood Leak 3 3
Mechanical Problem 3 3
Melted 2 2
False Positive Result 2 2
Fire 2 2
Fail-Safe Problem 2 2
Computer Software Problem 1 1
Electrical /Electronic Property Problem 1 1
Flushing Problem 1 1
Component Missing 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 26 26
Therapeutic Response, Increased 10 10
Needle Stick/Puncture 9 9
Misdiagnosis 7 7
No Code Available 7 7
No Consequences Or Impact To Patient 6 6
Venipuncture 3 3
No Information 3 3
Test Result 2 2
Abrasion 2 2
Death 2 2
Emotional Changes 1 1
Eye Injury 1 1
Overdose 1 1
Exposure to Body Fluids 1 1
Missed Dose 1 1
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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