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	09/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is ongoing, a follow up report will be submitted to share the conclusions.Na.
Event or Problem Description
A customer from india alleged discrepant results for one patient when using cobas egfr mutation test v2.On (b)(6) 2022 a plasma sample was tested using cobas egfr mutation test v2 and generated an ex19del mutation detected result.On (b)(6) 2022, a tissue sample from the same patient was tested using cobas egfr mutation test v2 and ex19del mutation was not detected.No harm alleged to date.
Additional Manufacturer Narrative
Data was provided and reviewed.A review of the growth curves showed no abnormalities.Furthermore, there was no sign of growth in the ex19del in the tissue sample.Controls were valid and internal controls generated robust results.The observed discrepancy is most likely due to the differences between the sample specimen types (tissue vs plasma).The plasma specimen represents the amount of mutations in the cell-free dna during the time of blood collection whereas tissue contains dna that was collected during biopsy.Although the tissue is considered a "golden standard", it is possible that the ffpet (tissue) slide used for testing did not contain any/very low amount of ex19del mutation whereas the cfdna contained more.In addition, there are differences in results calculations between plasma and tissue specimen types.

• 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; na; branchburg NJ 08876
• Manufacturer Contact: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16628888
• Report Number: 2243471-2023-00169
• Device Sequence Number: 12093254
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 04/06/2023

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: 12/31/2023
• Device Catalogue Number: 07248563190
• Device Lot Number: J05038
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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