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 06/22/2022

Event Type  malfunction  

Event Description

A customer from spain alleged discrepant results with one sample using with the cobas egfr mutation test v2.The alleged sample is from a patient who was previously diagnosed with the ex19del mutation in order to detect if any resistance mutations developed.When testing the sample from the first extraction of cfdna, the result was mutation detected for t790m mutation only.The customer repeated the cfdna extraction to re-test the sample.In this case, the result was mutation detected for ex19del, but the t790m mutation was not detected.Subsequently, a new blood collection was performed and the sample was re-tested in duplicate.The results were 1) ex19del and t790m mutations detected and 2) ex19del mutation detected and t790m was not detected.No harm or injury alleged.

Manufacturer Narrative

The investigation of the reagents did not show any product malfunction.The t790m mutation discrepancy is due to a low number of mutations in the sample; the ctr values are near the lod of the assay, which may cause varying results.The root cause of the mutation not detected (nan) in the initial run on (b)(6) 2022 for the ex19del is unknown.In all subsequent testing of the sample, the ex19del was present and generated robust ct values.The ex19del discrepancy could be related to workflow practices.

• 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: 15080163
• MDR Text Key: 304716892
• Report Number: 2243471-2022-00617
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 07/21/2022

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: 04/30/2023
• Device Catalogue Number: 07248563190
• Device Lot Number: H14612
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/21/2022
• 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