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	02/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is on-going.J05038 = expiration date: 2023-12-31.J10355 = expiration date: 2024-03-31.J18917 = expiration date: 2024-06-30.E1 facility name truncated due to character limit:(b)(6) hospital.
Event or Problem Description
A customer from the united kingdom alleged discrepant results with the cobas® egfr mutation test v2.The customer reported that 5 patient samples showed mutation detected ((b)(4)), and no mutation detected during initial and repeat testing.
Additional Manufacturer Narrative
A review of the data showed that out of 5 alleged samples 4 were at the limit of detection (lod) of the assay which explains the wavering results during repeat testing or sample stability issues.It was noted that some of the samples were tested outside of the method sheet instructions; "extracted dna is stable for up to 14 days at 2°c to 8°c." note, that a 6th sample was also alleged to have generated discrepant results that was found to be near the lod of the assay.The 5th sample was found to be related to a dirty lens in the detection unit of the cobas z 480 analyzer.The field service engineer visited the site and observed that the lens was dirty.The issue was resolved after the cleaning of the lens.The alleged result was not reported to the patient/treating physician.There is no allegation of harm.The issue has not reoccurred since.B6 and b5 were updated to include the additional 6th sample.
Event or Problem Description
The customer reported that 6 patient samples showed mutation detected (g719x or l858r or ex19del), and no mutation detected during initial and repeat testing.

• 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 ; 9253534412
• MDR Report Key: 17483340
• Report Number: 2243471-2023-02559
• Device Sequence Number: 15148621
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 10/04/2023

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,J10355,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: 07/10/2023
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 10/04/2023
• 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