MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS® EGFR MUTATION 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)

Patient Problems Solid Tumour (4552); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

A customer from spain alleged patient samples generated discrepant results for ex20ins when tested with the cobas egfr mutation test v2 and ngs.When initially tested 9 samples generated exon 20 insertion mutation with cobas® egfr mutation test v2.When sequenced (pangea), no exon20 insertion mutation results generated for all 8 of the 9 samples.Ngs analysis is pending for 1 sample.Results were reported to the medical personnel.No harm or injury was reported no further details were provided.An investigation was conducted to evaluate the customer issue.

Manufacturer Narrative

The investigation is on-going.A supplemental will be filed upon completion of the investigation.(b)(4).

Event Description

A customer from spain alleged patient samples generated discrepant results for ex20ins when tested with the cobas egfr mutation test v2 and ngs.When initially tested (b)(4) samples generated exon 20 insertion mutation with cobas® egfr mutation test v2.When sequenced (pangea), no exon20 insertion mutation results generated for all (b)(4) samples.Ngs analysis which was pending for 1 sample.Analysis was completed no mutation was detected results were reported to the medical personnel.No harm or injury was reported.An investigation was conducted to evaluate the customer issue.

Manufacturer Narrative

This is a supplemental follow up to provide the investigation conclusion to.The case summary in b5 has been updated to reflect the new information.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).(b)(4).

• 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: 12796701
• MDR Text Key: 285406850
• Report Number: 2243471-2021-03688
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/24/2021

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 Catalogue Number: 07248563190
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/15/2021
• Supplement Dates FDA Received: 11/24/2021
• 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
• Removal/Correction Number: 2243471-08-24-2021-003-C
• Patient Sequence Number: 1