BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ION TORRENT¿ ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY

    MDR report key: 8122601 · Received December 1, 2018

    Report

    Report Number
    3003335080-2018-00002
    Event Type
    Malfunction
    Date Received
    December 1, 2018
    Date of Event
    October 29, 2018
    Report Date
    November 30, 2018
    Manufacturer
    LIFE TECHNOLOGIES CORPORATION
    Product Code
    OTV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962591 ION TORRENT¿ ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY ONCOMINE LUNG CELL-FREE TOTAL NUCLEIC ACID (CFTNA) RESEARCH ASSAY OTV LIFE TECHNOLOGIES CORPORATION 2025404

    Patients

    Seq Age Sex Outcome Treatment
    1