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

Catalog Number 07248563190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

A customer from (b)(6) alleged discrepant results for multiple samples.Cobas egfr test detected mutations, including double mutations (ex19del, l858r), and sanger sequencing and rotogene did not.The customer is running off-label, using 30um instead of 5 um of section of tissue sample.Per the instructions for use, only nsclc ffpet sections of 5-um thickness containing at least 10% tumor content by area are to be used in the cobas egfr test, v2.0.No harm or injury was indicated.Two mdrs will be filed.

Manufacturer Narrative

Investigation is ongoing.A follow-up report will be filed upon the completion of the investigation.(b)(4).

Manufacturer Narrative

No kit issues were identified during the course of the investigation.Performance testing of the complaint kit batch f25967 was performed and all results were valid and the kit met validation and acceptance criteria.It is possible that the discrepancies observed are caused by a combination of any of these factors, including but not limited to the customer's off-label workflow, differences between technologies, or ctr at the lod of the assay.(b)(4).

• Brand Name: COBAS EGFR TEST V2
• Type of Device: SOMATIC GENE MUTATION DETECTION SYSTEM
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC.; 1080 us highway 202 south; branchburg NJ 08876
• MDR Report Key: 11329731
• MDR Text Key: 280452005
• Report Number: 2243471-2021-00336
• Device Sequence Number: 1
• Product Code: OWD
• Combination Product (y/n): N
• PMA/PMN Number: P120019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

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: 09/30/2021
• Device Catalogue Number: 07248563190
• Device Lot Number: F25967
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1