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	11/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is ongoing.
Event or Problem Description
A customer from hong kong alleged discrepant results with 3 patient samples using the cobas egfr mutation test, v2.Patient 1 initially generated no mutation detected result on (b)(6) 2022.The sample was sent for ngs in 2022 which generated l858r mutation detected result.A new specimen was collected in (b)(6) 2023 and tested on (b)(6) 2023 using the cobas egfr v2 test which generated l858r mutation detected result.Patient 2 initially generated no mutaton detected on (b)(6) 2023.The sample was sent for ngs which generated e709a;g179a mutation detected result.On (b)(6) 2023, the sample was retested on the cobas egfr v2 test and generated g179x mutation detected result.Patient 3 initially generated no mutation detected result on (b)(6) 2023.The sample was repeated on the cobas egfr v2 test which generated l858r mutation detected result.
Additional Manufacturer Narrative
No product problem identified.The root cause contributing to the discrepant results observed by the customer is sample/site specific such as sample at the limit of detection (lod) and/or suboptimal workflow.Note, for the patient 1 sample, the off-label sample type (pericardial fluid) was likely a contributing factor.Per the method sheet, "the cobas egfr test has been validated for use with nsclc ffpet tumor samples and plasma separated from blood collected in the roche cfdna tube or k2 edta tube.".

• 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: 18232238
• Report Number: 2243471-2023-03793
• Device Sequence Number: 11589688
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): Y
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: 06/30/2024
• Device Catalogue Number: 07248563190
• Device Lot Number: J18917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/19/2023
• 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