MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORPORATION ONCOMINE DX TARGET TEST PRODUCT

Catalog Number A32451

Device Problems Off-Label Use (1494); Unexpected Therapeutic Results (1631)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Catalog #: a32451 is a "master lot managed sku" which is not held in inventory.This sku is used for the customer to order the oncomine¿ dx target test, which includes the oncomine¿ dx target test guides and assay definition file software (catalog #: a32461); (b)(4).Oncomine¿ dx target test guides and assay definition file software (catalog #: a32461) is considered to have the product malfunction in this event the oncomine¿ dx target test guides and assay definition file software is a commpliation of files on a usb and has no expiration date listed on the product label.For catalog #: a32461.An investigation of the oncomine¿ dx target test design, labeling, and software showed that the off label use of the product to test a neck lymphnode sample with the braf v600k variant, and the proximity of the of the braf v600k variant to the braf v600e variant cause the test to report out braf v600e and a treatment recommendation based on the presence of the variant.The customer stated that they knowingly entered the neck lymphnode sample into the oncomine¿ dx target test system as a non-small cell lung cancer (nsclc) sample and chose "nsclc" in the dropdown menu instead of "other" in order to generate a report for their verification exercise.The use of a neck lymphnode sample by the customer, and the incorrect "nsclc" classification in the system was the reason the customer received a report indicating the presence of braf v600k and braf v600e variants.While the presence of braf v600k had no clinical indication, the presence of braf v600e variant indicated candidacy for the treatment plan tafinlar® (dabrafenib) in combination with mekinist® (trametinib).If this occurred in the field, a false positive call for braf v600e may occur.A review of the software used for the oncomine¿ dx target test was completed.The software drop down menu for "cancer type" provided 2 options: "nsclc" and "other." the software did not automatically distinguish sample types, but relied on input from the operator to identify which cancer type was being assessed.When "other" was selected, the software did not generate lab and test reports or provide any associated therapy options.However, variant calls for samples selected as "other," could still be viewed in the user interface under the corresponding tabs.When "nsclc" was entered into the system, the software generated lab and test reports, provided associated recommended therapies, and variant calls could be viewed in the user interface under the corresponding tabs.The review of the assay definition file (adf v1.8) was performed.Hotspots (predefined gene sequence changes, or variants, (snvs, mnvs, and deletions) that differed from the reference sequence) were identified in the adf.A review of the adf showed that braf v600e and braf v600k were defined as overlapping variants.While the presence of braf v600k in nsclc samples is considered highly unlikely, this adf file design, which overlapped variants, may have caused an issue when a non-nsclc tissue sample positive for braf v600k was used for detecting variants found in nsclc samples.No operational errors or system bugs were discovered during the review of the product software.It is considered highly unlikely that an interpretation discrepancy between braf v600k / braf v600e variants would occur in nsclc patient samples.However, a notification to customers and labs using the oncomine¿ dx target test has been distributed to notify users of the variant discrepancy.The regional fda recall coordinator and cdrh have been notified of the issue and communication between thermo fisher scientific and the agency is ongoing.The following immediate corrections are being implemented: existing customers: all impacted customers will receive a customer notification letter to inform them of the issue.New customers: the oncomine dx target test training materials will be updated to provide details relating to this issue.Long term corrective action: the torrent suite dx software and/or the assay specific assay definition file (adf) will be updated to correct the incorrect calling of braf v600e in the presence of braf v600k.The completion of the software and/or adf validation will occur in q2 2018 and is planned to be included in an spma to fda.

Event Description

A user facility with the oncomine dx target test, a device approved for use with non-small cell lung cancer (nsclc) samples, used the test off label to run a neck lymphnode sample with a known braf v600k gene variant.The sample was run for verification purposes only.The test report details obtained for the neck lymphnode sample returned positive results for braf v600k as well as braf v600e (clinical variant associated with the approved use), and recommend a course of treatment with tafinlar® (dabrafenib) in combination with mekinist® (trametinib).No patient samples were used.No patient care management decisions were made from the verification run.No death or serious injury was reported by the user.

• Brand Name: ONCOMINE DX TARGET TEST PRODUCT
• Type of Device: ONCOMINE DX TARGET TEST PRODUCT
• Manufacturer (Section D): LIFE TECHNOLOGIES CORPORATION; 7335 executive way; frederick MD 21704
• Manufacturer (Section G): LIFE TECHNOLOGIES CORPORATION; 7305 executive way; frederick MD 21704
• Manufacturer Contact: kelli tanzella ; 3175 staley road; grand island, NY 14072 ; 7167743122
• MDR Report Key: 7121097
• MDR Text Key: 95733991
• Report Number: 3003335080-2017-00001
• Device Sequence Number: 1
• Product Code: PQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: A32451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1