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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reader, cervical cytology slide, automated
Product CodeMNM
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
1 4 1 3 1 3 3 3 0 1 2 0 2 1 0 0

MDR Year MDR Reports MDR Events
2014 5 5
2015 3 3
2016 3 3
2017 8 8
2018 2 2
2021 2 2
2022 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
False Negative Result 10 10
Device Operates Differently Than Expected 3 3
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 2 2
Incorrect Or Inadequate Test Results 2 2
Structural Problem 1 1
Date/Time-Related Software Problem 1 1
Device Displays Incorrect Message 1 1
Device Markings/Labelling Problem 1 1
Image Display Error/Artifact 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Separation 1 1
Device Stops Intermittently 1 1
Improper or Incorrect Procedure or Method 1 1
Appropriate Term/Code Not Available 1 1
Output Problem 1 1
Break 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 10 10
No Clinical Signs, Symptoms or Conditions 7 7
No Code Available 4 4
No Information 3 3
Abdominal Pain 1 1
Hemorrhage/Bleeding 1 1
Rash 1 1
Chills 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Becton Dickinson & Co. III Oct-05-2018
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