TPLC - Total Product Life Cycle

• 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 Code: OWD
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
15	13	12	24	9	1

MDR Year	MDR Reports	MDR Events
2020	3	3
2021	57	57
2022	53	53
2023	15	15
2024	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
False Positive Result	113	113
Non Reproducible Results	16	16
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Output Problem	11	11
False Negative Result	5	5
Off-Label Use	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	123	123
Solid Tumour	98	98
No Consequences Or Impact To Patient	4	4
Insufficient Information	2	2
Diarrhea	2	2
Therapeutic Response, Decreased	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Liver Damage/Dysfunction	1	1
Fatigue	1	1
Keratitis	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