MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORPORATION ONCOMINE (TM) DX TARGET TEST; ONCOMINE DX TARGET TEST

Model Number	A32441
Medical Device Problem Codes	False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Catalog #: a32451 is the identifier used for customers to order the oncomine dx target test.It is considered a "lot managed sku" which is not held in inventory, but provides instruction regarding which products will ship for the customer order.The oncomine dx target test rna/dna panel is only shipped as part of catalog #: a32451, but for traceability purposes, has it's own product identifiers: oncomine dx target test rna/dna panel, catalog #: a32441, lot #: 1705001, (b)(4).Since the oncomine dx target test rna/dna panel can only be ordered as part of the oncomine dx target test (catalog #: a32451), the oncomine dx target test is considered the affected product in the field.The date received by manufacturer is considered february 13, 2018.This is the date the clinical relevance of the low oligonucleotide concentration became available.On february 13, 2018 information regarding possible false negatives or "no calls" in the field were reported by thermo fisher scientific r&d to the investigation team.February 13, 2018 is considered the date thermo fisher scientific became aware of a mdr reportable event.Manufacturer narrative: the root cause of the low oligonucleotide concentration in the oncomine dx target rna/dna panel (catalog #: a32441) has been determined to be the inadvertent addition of the deionized water during filling of the bulk rna oligo solution during the lot manufacturing process.Bulk oligo solution was thawed, vortexed and then centrifuged using a counterweight containing di water.The operator mistakenly poured di water from the counterweight into the fill reservoir instead of the bulk oligo solution to complete the pipetting and fill/finish process of the rna panel.Customers were notified of the issue on february 16, 2018 and instructed to review any patient test results obtained using the defective product.Customers were advised to retest patient samples which resulted in a "no call" or negative result for a ros1 variant using an alternative test method if one was not previously performed.Patients tested with the defective rna panel may be at risk for receiving a false negative result.Only patients with a ros1 variant (1%-2% of the patient population) would be at risk for a false negative result and possibly be excluded from treatment with xalkori.
Event or Problem Description
An internal investigation of the oncomine dx target test rna/dna panel (lot# 1705001), a component of the oncomine dx target test, revealed a manufacturing error caused a low oligonucleotide concentration in the rna panel of the final product.The low oligonucleotide concentration may cause the oncomine dx target test to malfunction and produce no test results, or false negative test results to be reported to a clinician when the oncomine dx target test is being used to determine the presence of a ros1 gene variant in patients with non-small cell lung cancer (nsclc).Nsclc patients identified with a ros1 gene variant may be candidates for the drug xalkori (crizotinib).Clinical studies for xalkori showed that 66% of the study participants with nsclc that had spread to other parts of the body experienced lessened metastasis, shrunken tumors, or no signs of cancer.Individuals who were given xalkori also had a median time period of 18.3 months before noticable tumor growth/metastasis occured.A false negative test result for a ros1 variant may exclude a patient from receiving xalkori and the possible therapeutic benefits of the drug.The product malfunction was discovered internally.No reports of product malfunction, patient death or serious injury was received from customers.

• Brand Name: ONCOMINE (TM) DX TARGET TEST
• Common Device Name: ONCOMINE DX TARGET TEST
• Manufacturer (Section D): LIFE TECHNOLOGIES CORPORATION; 7335 executive way; frederick MD 21704
• MDR Report Key: 7293259
• Report Number: 3003335080-2018-00001
• Device Sequence Number: 957728
• Product Code: PQP
• UDI-Device Identifier: 10190302006385
• UDI-Public: (01)10190302006385(17)180220(10)1705001(240)A32441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 02/20/2018
• Device Model Number: A32441
• Device Catalogue Number: A32441 (A PART OF A32451)
• Device Lot Number: 1705001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3003335080-2018-002-C
• Patient Sequence Number: 1