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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 COMPANY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 34 34
Low Test Results 13 13
High Test Results 12 12
Use of Device Problem 10 10
Adverse Event Without Identified Device or Use Problem 9 9
Incorrect Or Inadequate Test Results 5 5
Improper or Incorrect Procedure or Method 3 3
Contamination /Decontamination Problem 3 3
Data Problem 2 2
Device Handling Problem 2 2
Smoking 1 1
Electrical /Electronic Property Problem 1 1
Flushing Problem 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 59 59
No Clinical Signs, Symptoms or Conditions 26 26
Therapeutic Response, Increased 4 4
Needle Stick/Puncture 4 4
Abrasion 2 2
No Consequences Or Impact To Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Instrumentation Laboratory II Sep-12-2023
2 Instrumentation Laboratory II Apr-28-2022
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