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 Negative Result (1225)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is on-going.A supplemental mdr will be filed upon completion of the investigation.

Event Description

A customer from spain alleged discrepant results for one patient when using the cobas egfr mutation test v2.The alleged sample was initially tested using the cobas egfr mutation test v2 and generated a "no mutation detected" result.A retest was performed using next generation sequencing (ngs) which detected l858r (vaf 7%).The sample was retested once again on the cobas egfr mutation test v2 and generated "mutation detected" result for l858r.No harm alleged.An investigation is ongoing to evaluate the customer issue.

Manufacturer Narrative

No product problem was identified.The discordant results are due to the sample being near the limit of detection (lod) of our assay.Samples near the lod can waver between "detected" and "no mutation detected" with repeat testing.Per the method sheet, a "no mutation detected" result does not preclude the presence of a mutation in the targeted egfr regions because results depend on percent mutant sequences, adequate sample integrity, absence of inhibitors, and sufficient dna to be detected.Of note, the 4 slides from ffpet used are from a "real sample", which is not expected to have any of its result reported out, just for laboratory certification and result concordance.

• 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: timothy blair ; 1080 us hwy 202 s; building 500, room: 3530; branchburg, NJ 08876 ; 9253534412
• MDR Report Key: 16037680
• MDR Text Key: 308371987
• Report Number: 2243471-2022-01073
• Device Sequence Number: 1
• Product Code: OWD
• 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,Followup
• Report Date: 01/19/2023

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 Catalogue Number: 07248563190
• Device Lot Number: ASKU
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/13/2023
• Supplement Dates FDA Received: 01/19/2023
• 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