ONCOMINE DX TARGET TEST PRODUCT A32451

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-15 for ONCOMINE DX TARGET TEST PRODUCT A32451 manufactured by Life Technologies Corporation.

Event Text Entries

[95733991] 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.
Patient Sequence No: 1, Text Type: N, H10


[95733992] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003335080-2017-00001
MDR Report Key7121097
Date Received2017-12-15
Date of Report2017-11-21
Date of Event2017-11-21
Date Mfgr Received2017-11-21
Date Added to Maude2017-12-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR. KELLI TANZELLA
Manufacturer Street3175 STALEY ROAD
Manufacturer CityGRAND ISLAND NY 14072
Manufacturer CountryUS
Manufacturer Postal14072
Manufacturer Phone7167743122
Manufacturer G1LIFE TECHNOLOGIES CORPORATION
Manufacturer Street7305 EXECUTIVE WAY
Manufacturer CityFREDERICK MD 21704
Manufacturer CountryUS
Manufacturer Postal Code21704
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameONCOMINE DX TARGET TEST PRODUCT
Generic NameONCOMINE DX TARGET TEST PRODUCT
Product CodePQP
Date Received2017-12-15
Catalog NumberA32451
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIFE TECHNOLOGIES CORPORATION
Manufacturer Address7335 EXECUTIVE WAY FREDERICK MD 21704 US 21704


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-15

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