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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer is (b)(6) the investigation is ongoing.
Event or Problem Description
There was an allegation of questionable cobas® egfr mutation test v2 assay results for 7 patient samples tested on a cobas z 480 analyzer.Date: (b)(6) 2025 sample 1: initial result: mutation detected ex19del repeat result: no mutation detected.Date: (b)(6) 2025 sample 2: initial result: mutation detected ex19del repeat result: no mutation detected.Date: (b)(6) 2025 sample 3: initial result: mutation detected ex19del repeat result: mutation detected; ex19del, t790m.Date: (b)(6) 2025 sample 4: initial result: mutation detected ex19del repeat result: no mutation detected.Sample 5: initial result: mutation detected ex19del repeat result: no mutation detected.Date: (b)(6) 2025 sample 6: initial result: mutation detected ex19del, t790m repeat result: mutation detected; ex19del.Date: (b)(6) 2025 sample 7: initial result: mutation detected; ex19del, t790m repeat result: mutation detected; ex19del.
Additional Manufacturer Narrative
Due to limited information, a conclusive root cause could not be determined.Discrepancies could occur due to sample-specific issues, such as containing a low percentage mutation near the limit of detection of the assay or a sample quality issue.Other potential factors could be due to pre-analytical sample and reagent handling.Per the procedure limitation section of the method sheet for the cobas® egfr mutation, "detection of a mutation is dependent on the number of copies present in the sample and may be affected by sample integrity, amount of isolated dna, and the presence of interfering substances.Reliable results are dependent on adequate transport, storage and processing.Follow the procedures in the cobas® cfdna sample preparation kit, these instructions for use, and in the cobas® 4800 system - user assistance." the investigation did not identify a product problem.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 24022098
• Report Number: 2243471-2026-00125
• Device Sequence Number: 13407684
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P150044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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 Catalogue Number: 07248563190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/19/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 02/09/2026
• 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