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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device somatic gene mutation detection system
Definition The somatic gene mutation detection system is an in vitro diagnostic nucleic acid amplification and real-time detection system for the identification of genetic mutations in DNA extracted from human tumor tissues.
Product CodeOWD
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 3 4 10 6 31 21 17 36 16 15 13 12 24 2

MDR Year MDR Reports MDR Events
2014 2 2
2015 1 1
2016 1 1
2017 2 2
2020 3 3
2021 57 57
2022 53 53
2023 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
False Positive Result 112 112
Incorrect, Inadequate or Imprecise Result or Readings 14 14
Non Reproducible Results 12 12
Output Problem 11 11
Incorrect Or Inadequate Test Results 4 4
False Negative Result 3 3
Off-Label Use 3 3
Signal Artifact/Noise 2 2
Insufficient Information 2 2
Device Operates Differently Than Expected 1 1
Incorrect Measurement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 118 118
Solid Tumour 98 98
No Known Impact Or Consequence To Patient 6 6
No Consequences Or Impact To Patient 4 4
Therapeutic Response, Decreased 2 2
Insufficient Information 2 2
Diarrhea 2 2
Fatigue 1 1
Keratitis 1 1
Liver Damage/Dysfunction 1 1
No Information 1 1
Cancer 1 1
Stomatitis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Qiagen GmbH II Sep-29-2023
2 Qiagen Sciences LLC II Aug-29-2022
3 Qiagen Sciences LLC II Apr-19-2022
4 Qiagen Sciences LLC II Jan-29-2021
5 Roche Molecular Systems, Inc. II Oct-08-2021
6 Roche Molecular Systems, Inc. II Jul-21-2016
7 Roche Molecular Systems, Inc. II May-26-2016
8 Roche Molecular Systems, Inc. III Jun-26-2015
9 Roche Molecular Systems, Inc. III Mar-25-2015
10 Roche Molecular Systems, Inc. III Nov-02-2012
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