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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)
2019 2020 2021 2022 2023 2024
16 15 13 12 24 2

MDR Year MDR Reports MDR Events
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 13 13
Non Reproducible Results 12 12
Output Problem 11 11
Off-Label Use 3 3
False Negative Result 3 3
Signal Artifact/Noise 2 2
Insufficient Information 2 2
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 Consequences Or Impact To Patient 4 4
Therapeutic Response, Decreased 2 2
Diarrhea 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Fatigue 1 1
Keratitis 1 1
Liver Damage/Dysfunction 1 1
No Known Impact Or Consequence To Patient 1 1
Cancer 1 1
Stomatitis 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
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