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

Catalog Number 07248563190

Device Problem False Positive Result (1227)

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

Event Date 10/18/2022

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed to provide conclusions of the investigation.

Event Description

A customer from singapore alleged discrepant results for one patient when using the cobas egfr mutation test v2.The sample was initially tested on the cobas egfr mutation test v2 and generated a "mutation detected" for exon 19 deletion.Two subsequent retests of the same specimen using sanger sequencing detected exon 19 duplication.Both the egfr cobas result and egfr sanger results were reported to the clinician.There is no allegation of a delay in treatment for this patient.The patient was provided tki according to the customer.An investigation is on going to evaluate the customer issue.

Manufacturer Narrative

An investigation concluded that the false-positive result for ex19del is due to cross-reactivity with ex19dup (insertion)-cosm id# 26443 as there is a perfect match to one of the cobas® egfr mutation test v2 primers.This limitation is reflected in the us instructions for use of the assay.Its procedural limitation section states the following: "though rare, mutations within the genomic dna regions of the egfr gene covered by the primers or probes used in the cobas egfr test may lead to an incorrect result." this limitation is unlikely to have a safety impact.In the cases where the presence of egfr ex19 insertion/duplication is detected, a patient may still be considered for tki therapy and similarly to egfr ex19del, and would not be eligible for immunotherapy.

Manufacturer Narrative

Added component code.

• 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: 15971421
• MDR Text Key: 308287966
• Report Number: 2243471-2022-01031
• Device Sequence Number: 1
• Product Code: OWD
• UDI-Device Identifier: 00875197005448
• UDI-Public: 00875197005448
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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,Followup
• Report Date: 02/16/2023

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: 11/14/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 02/07/2023; 02/07/2023
• Supplement Dates FDA Received: 02/08/2023; 02/16/2023
• 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
• Patient Age: 81 YR
• Patient Sex: Male