MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION TEST V2; SOMATIC GENE MUTATION DETECTION SYSTEM

Catalog Number 07248563190

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Event Description

A customer from greece alleged discrepant results with 1 patient sample using the cobas® egfr mutation test v2.The alleged sample initially tested with the cobas® egfr mutation test v2 generated a "mutation detected" result for exon20ins.The sample was retested using next generation sequencing (ngs) and was negative for the ex20ins.

Manufacturer Narrative

Dna isolation was performed using 3 sections of 5mm.The method sheet of cobas® dna sample preparation kit (m/n (b)(4)) provides instructions to start with one slide 5-m thick ffpet section for sample preparation roche received complaints from customers reporting the generation of false mutation detected results for the exon 20 insertion (ex20ins) mutation when using the cobas® egfr mutation test v2.During in-house testing using customer-provided ffpet samples, an ex20ins false mutation detected result was reproduced for one out of 8 ffpet samples, which was processed following the validated sample preparation method from the instructions for use.Although the majority of cases reported were from users using ffpet samples, the generation of false mutation detected ex20ins results with plasma specimens was reported in one case.A false mutation detected ex20ins result could lead to harm under specific scenarios.Consignees have been notified of the issue with instruction to follow the instructions for use for sample input requirements.Additionally, if an ex20ins mutation detected result is generated with the cobas® egfr mutation test v2, customers must confirm the result with another method (e.G., sequencing or other pcr-based tests).

• Brand Name: COBAS® EGFR MUTATION TEST V2
• Type of Device: 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: 18185433
• MDR Text Key: 328705431
• Report Number: 2243471-2023-03735
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (y/n): Y
• Reporter Country Code: GR
• PMA/PMN Number: P150047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 07248563190
• Device Lot Number: J05038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0083-2022 RES88607
• Patient Sequence Number: 1