MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION TEST V2 P150044; SOMATIC GENE MUTATION DETECTION SYSTEM

Catalog Number	07248563190
Medical Device Problem Codes	False Negative Result (1225); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
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 unknown number of patient samples tested on cobas z480 analyzer.On (b)(6) 2025 (plasma sample) result was "no mutation detected".On (b)(6) 2025 (tissue sample) result was "no mutation detected".On an unknown date, a sequencing (ngs) test was performed and the result was del19 and l858r detected.On an unknown date, another non-roche pcr test was performed and the result was del19 and l858r detected.
Additional Manufacturer Narrative
The investigation findings concluded no product issue was identified.The likely root cause of the discrepancies is the customer workflow due to off-label quantification method and differences in technology.

• Brand Name: COBAS® EGFR MUTATION TEST V2 P150044
• 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 ; 9253534412
• MDR Report Key: 21706518
• Report Number: 2243471-2025-00896
• Device Sequence Number: 13279988
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/23/2025
• 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