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

Catalog Number 07248563190

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005); Non Reproducible Results (4029)

Patient Problems No Consequences Or Impact To Patient (2199); Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer from (b)(6) observed result discrepancies with ex20 ins when using two 5 micron ffpet sections for extraction for one patient sample.No harm is alleged.

Manufacturer Narrative

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 will be 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).Correction to device code from non-reproducible results to false positive result (b)(4).

• Brand Name: COBAS EGFR 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
• MDR Report Key: 11205737
• MDR Text Key: 244857682
• Report Number: 2243471-2021-00142
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

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: 12/21/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2243471-08-24-2021-003-C
• Patient Sequence Number: 1