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

Catalog Number 07248563190

Device Problem Non Reproducible Results (4029)

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

Event Date 07/15/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.Facility name truncated due to character limit: (b)(6).

Event Description

A customer from the united kingdom alleged discrepant results with the cobas® egfr mutation test v2.The alleged sample was tested with the cobas® egfr mutation test v2 which resulted in g719x mutation detected.The sample was retested with another method (biocartis idylla) and no mutation was detected.The result was reported to the medical personnel.No harm alleged.

Manufacturer Narrative

Based on the analysis of the data, result discrepancy may be expected between assays due to potential differences in technology.A detailed data analysis did not identify any issues and nothing was observed on the plates that seem to indicate contamination of sample wells.The samples appear to be true calls by the cobas® egfr mutation test v2.It was indicated if the customer performed retests of the patient samples with biocartis's idylla test, using resection of the ffpet block and if the slides are not adjacent to one another, it is possible the tumor heterogeneity may lead to discordant results between methods.

• 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; na; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 15236892
• MDR Text Key: 305363336
• Report Number: 2243471-2022-00692
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 07248563190
• Device Lot Number: H31955
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1