MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION TEST V2; SOMATIC GENE MUTATION DETECTION SYSTEM

Catalog Number	07248563190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).Investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results with the cobas® egfr mutation test v2 assay for one patient sample tested on cobas z480 analyzer.On (b)(6) 2024, the initial result (plasma sample) was exon19 del mutation detected.On an unknown date, a sequencing (ngs) test was performed and the result was mutation not detected.On (b)(6) 2024, a new plasma extraction was run on the cobas z480 analyzer and the result was mutation not detected.The questionable results were not reported outside the lab.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The issue was found to be sample-specific as the wavering results were due to the low levels of mutation which generated a ct value near the limit of detection for the exon 19 del target.According to the method sheet, "detection of a mutation is dependent on the number of copies present in the specimen and may be affected by sample integrity, amount of isolated dna, and the presence of interfering substances.".

• Brand Name: COBAS® EGFR MUTATION TEST V2
• Common Device Name: SOMATIC GENE MUTATION DETECTION SYSTEM
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer (Section G): ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; branchburg, NJ 08876
• MDR Report Key: 20640995
• Report Number: 2243471-2024-03238
• Device Sequence Number: 7367210
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P150047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 07248563190
• Device Lot Number: K19029
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown