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 Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; +1(925)353-4412
• MDR Report Key: 50946527
• Report Number: 2243471-2026-04019
• Device Sequence Number: 10452003
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P150044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: P00471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/30/2026
• 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