MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS COBAS EGFR MUTATION TEST; EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION / MRNA EXPRESSION IVD, NAT

Catalog Number 06471463190

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2014

Event Type  No Answer Provided  

Event Description

A customer site in (b)(6) filed a complaint alleging that a sample was identified as wild type (mutation not detected) but was expected to be a g719x mutant when using the cobas egfr mutation test, lot t05841.The sample was an ffpe panel sample.When the sample and slides were sent back to the sample provider, the provider confirmed the g719x mutation using the entrogen assay.A new extraction was performed and run with the cobas egfr mutation test at the customer site and again generated a mutation not detected result.

Manufacturer Narrative

A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing.The outcome of this investigation will be communicated through a follow-up report.Note: product code nqf was selected as the closest available code.Nqf is immunohistochemistry assay egfr.The product in this mdr is a nucleic acid test (nat) for egfr.Cobas egfr mutation test ivd udi (b)(4).The associated us product shares the same identification above.Pma p120019.(b)(4).

Manufacturer Narrative

Date additional information was received by the manufacturer: 13-feb-2015.Follow up report 1.Additional information/device evaluation.Device evaluated by manufacturer yes.(b)(4).A customer in (b)(6) alleged false mutation not detected g719x results for ffpet samples while performing a validation study with the cobas egfr mutation test; a competitor assay (entrogen) generated mutation detected results for g719x.The ffpet samples were returned and subjected to sequencing, which revealed wild-type mutations for egfr.As sequencing did not detect any g719x mutations, the mutation not detected results generated for the samples with the cobas egfr mutation test at the customer site are expected.Investigative testing was performed on the retain kit t05841 and met specifications.Based on the results of sequencing analysis and retain testing, no product malfunction was identified and the test performed as intended with the particular ffpet samples.(b)(4).

• Brand Name: COBAS EGFR MUTATION TEST
• Type of Device: EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) GENE MUTATION / MRNA EXPRESSION IVD, NAT
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS; 1080 us hw 202s; branchburg NJ 08876 373
• Manufacturer Contact: vincent stagnitto ; 1080 us hwy 202s; branchburg, NJ 08876-3733 ; 9082537569
• MDR Report Key: 4419759
• MDR Text Key: 5166207
• Report Number: 2243471-2015-00003
• Device Sequence Number: 1
• Product Code: OWD
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2015

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: Other
• Device Expiration Date: 08/30/2015
• Device Catalogue Number: 06471463190
• Device Lot Number: T05841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 01/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1