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	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results with the cobas® egfr mutation test v2.Patient 1 on (b)(6) 2024, the initial result was mutation not detected.On (b)(6) 2024, the same plasma sample was repeated and the result was exon19 del mutation detected.On (b)(6) 2024, a sequencing (ngs) test was performed with a tissue sample, and the result was exon19 del mutation detected.Patient 2 on (b)(6) 2024, the initial result was mutation not detected.On (b)(6) 2024, the same plasma sample was repeated and the result was exon19 del mutation detected.On an unknown date, a sequencing (ngs) test was performed with a tissue sample, and the result was exon19 del mutation detected.
Additional Manufacturer Narrative
The cobas z 480 serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
There was no indication of a product malfunction.The observed discrepancy was consistent with the variances between the sample types and the plasma samples being well below the limit of detection.
Additional Manufacturer Narrative
On (b)(6) 2024, the customer reported two additional samples with questionable results with the cobas® egfr mutation test v2.Patient 3 tested on (b)(6) 2024, initial result was mutation not detected.A sequencing (ngs) test was performed with a tissue sample, and the result was s768i mutation detected and the dna concentration was 15ng/ul.Patient 4 tested on (b)(6) 2024, initial result was mutation not detected.A sequencing (ngs) test was performed with a tissue sample, and the result was exon19del mutation detected and the dna concentration was 4ng/ul.For these two additional samples, there was no indication of a product malfunction.The data showed no amplification was detected for both s768i and exon19del targets, which may indicate an insufficient amount of target dna for detection.

• 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: 20256942
• Report Number: 2243471-2024-02707
• Device Sequence Number: 7545716
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): Y
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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: 06/30/2025
• Device Catalogue Number: 07248563190
• Device Lot Number: K15109
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/07/2024; 10/09/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/08/2024; 10/22/2024
• 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