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	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable results with the cobas® egfr mutation test v2 assay with four patient samples tested on a cobas z480 analyzer.Sample 1: on (b)(6) 2025: the initial result was no mutation detected.The sample was repeated on another method (open qpcr instrument using test-gen kits (locally produced kit)) and the result was positive for the l858r mutation.The sample was sent for retesting to another laboratory (method unknown), where the mutation was confirmed.Sample 2: on (b)(6) 2025: the initial result was no mutation detected.The sample was repeated on a local test and l858r mutation was detected.Sample 3: on (b)(6) 2025: the initial result was l858r mutation detected.The sample was repeated on a local test and l858r and t790m mutations were detected.Sample 4: on (b)(6) 2025: the initial result was exon 19 del mutation detected.The sample was repeated on a local test and exon 19 del and t790m mutations were detected.
Additional Manufacturer Narrative
The root cause of the discrepant result for sample 1 is that the sample is near the limit of detection for l858r.Overall, the late critical threshold (ct) values generated in all the alleged samples indicate that the mutation levels are low.The ct values generated for the no mutation detected results are outside the threshold of detectability for the cobas egfr assay.According to the method sheet, the detection of a mutation is dependent on the number of copies present in the specimen and may be affected by sample integrity, amount of isolated dna, and the presence of interfering substances.A "no mutation detected" result does not preclude the presence of a mutation in the targeted egfr regions because results depend on percent mutant sequences, adequate sample integrity, absence of inhibitors, and sufficient dna to be detected.At this time, the product is working as intended.The local test may have different technologies and therefore have different detectability thresholds for each mutation.The investigation determined that the product is working as intended, and the allegation is sample-specific.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250 ; 9253534412
• MDR Report Key: 23378936
• Report Number: 2243471-2025-04332
• Device Sequence Number: 18442207
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P150044
• 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
• Report Date (Section B): 01/08/2026

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: M25692
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/28/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 01/08/2026
• 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