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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Product CodeMTF
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
7 10 26 19 16 14 8 6 12 10 8 14 6 5 10 1

MDR Year MDR Reports MDR Events
2014 10 10
2015 17 17
2016 16 16
2017 39 39
2018 30 30
2019 21 21
2020 14 14
2021 46 46
2022 45 45
2023 30 30
2024 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 111 111
Low Test Results 96 96
Adverse Event Without Identified Device or Use Problem 24 24
Device Ingredient or Reagent Problem 15 15
Incorrect Or Inadequate Test Results 15 15
Non Reproducible Results 14 14
Incorrect Measurement 13 13
Incorrect, Inadequate or Imprecise Result or Readings 12 12
No Apparent Adverse Event 4 4
Output Problem 2 2
Insufficient Information 2 2
No Device Output 1 1
Unable to Obtain Readings 1 1
Leak/Splash 1 1
High Readings 1 1
Low Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 135 135
No Known Impact Or Consequence To Patient 90 90
No Consequences Or Impact To Patient 58 58
Osteopenia/ Osteoporosis 9 9
Insufficient Information 4 4
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 BioMerieux SA II Aug-06-2014
2 Siemens Healthcare Diagnostics, Inc II Feb-04-2016
3 Siemens Healthcare Diagnostics, Inc. II Jan-31-2017
4 Siemens Healthcare Diagnostics, Inc. II Dec-22-2016
5 Siemens Healthcare Diagnostics, Inc. II May-11-2012
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