MAUDE Adverse Event Report: LIFE TECHNOLOGIES CORPORATION ION TORRENT¿ ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY

Catalog Number A35864

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 10/29/2018

Event Type  malfunction  

Manufacturer Narrative

The ion torrent¿ oncomine lung cell-free total nucleic acid (cftna) research assay is labeled "for research use only.Not for use in diagnostic procedures." (ruo) no patient impact at the biocept site was reported, however, the manufacturer, thermo fisher scientific, is submitting this mdr due to a possible false positive result` for the t790m variant at the (b)(6) if the lab utilizes the ruo product to assess patient samples.The unit in question was not returned by the customer.However, a different unit from the same lot was internally investigated by the manufacturer.This investigation is ongoing.Thermo fisher scientific has initiated the recall process to remove units of ion torrent¿ oncomine lung cell-free total nucleic acid (cftna) research assay lot #: 2025404 from the market.Affected customers have been contacted to stop use of the product.

Event Description

A representative from (b)(6), met with a customer representative from (b)(4) to discuss technical issues regarding validation activities at the (b)(6).(b)(6) complained that a possible contaminant in the ion torrent¿ oncomine lung cell-free total nucleic acid (cftna) research assay caused the genetic variant, t790m, to show positive in sample known to be negative for the variant.This was haulting the site's validation activities.No patient samples were being analyzed when the contamination was reported.The product was not used to determine treatment or diagnostic decisions.Ion torrent¿ oncomine lung cell-free total nucleic acid (cftna) research assay is labeled "for research use only.Not for use in diagnostic procedures." the product is not a cleared or approved medical device.

• Brand Name: ION TORRENT¿ ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY
• Type of Device: ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY
• Manufacturer (Section D): LIFE TECHNOLOGIES CORPORATION; 7335 executive way; frederick MD 21704
• Manufacturer (Section G): LIFE TECHNOLOGIES CORPORATION; 7335 executive way; frederick MD 21704
• Manufacturer Contact: kelli tanzella ; 7335 executive way; frederick, MD 21704
• MDR Report Key: 8122601
• MDR Text Key: 129753557
• Report Number: 3003335080-2018-00002
• Device Sequence Number: 1
• Product Code: OTV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/30/2019
• Device Catalogue Number: A35864
• Device Lot Number: 2025404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1