BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 13266496 · Received January 17, 2022

    Report

    Report Number
    1650733-2021-00025
    Event Type
    Malfunction
    Date Received
    January 17, 2022
    Date of Event
    December 14, 2021
    Report Date
    January 17, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL CASE DETAILS AGAINST THE CRITERIA SET FORTH IN DOCUMENT 00043 (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE) AND ITS APPLICABLE APPENDICES, THIS COMPLAINT DOES NOT MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE THE DEVICE IS SOLD OR DISTRIBUTED. HOWEVER, THE MDR IS BEING SUBMITTED TO US FDA PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Description of Event or Problem · 0

    ON 12/14/2021: CUSTOMER CALLED TO REPORT 1 N GENE WAS 'NOT DETECTED', BUT THE ORF1AB GENE WAS DETECTED. CUSTOMER SAID THIS IS THE FIRST TIME THEY HAVE SEEN THIS DISCREPANCY AND WOULD LIKE SOME CLARIFICATION ON WHAT MAY BE CAUSING THIS. ARIES RUN 1: SARS-POSITIVE. ARIES RUN 2: SARS NEGATIVE. CONFIRMATION TESTING: SARS NEGATIVE. PER THE ARIES PROTOCOL SOURCE FILE, AGILE DOCUMENT NUMBER 89-00010-00-502.01, THE TARGET DETECTION THRESHOLD FOR THE ARIES SARS-COV2 ASSAY TARGETS ARE BASED ON THE CALL LOGIC DEFINED IN TABLE 1 (TABLE 1: DATA SUMMARY). RNASE P PRIMERS AND PROBES ARE INCLUDED IN THE ARIES® SARS-COV-2 ASSAY AND IS THE INTERNAL SAMPLE PROCESSING CONTROL (SPC). THE RNASE P VERIFIES NUCLEIC ACID IS PRESENT IN EVERY SAMPLE, PROPER EXTRACTION, REVERSE-TRANSCRIPTION, AND PCR HAS OCCURRED. THE 6FAM CHANNEL FOR SARS-COV-2 ORF TARGET HAS A THRESHOLD FOR THE CT HIGH AS 39 AND >100,000 RFU. THE AP593 CHANNEL FOR THE SARS-COV-2 N TARGET HAS A THRESHOLD FOR THE CT HIGH AS 39 AND >400,000 RFU. THE AP662 CHANNEL FOR RNASE P (SPC), THE THRESHOLD FOR THE CT MEAN IS N/A. RUN 1 POSITIVE (M12V120287001-RUN#1465-A_202112) SAMPLE ID (B)(6) CASSETTE 1CVCAB4719220502A11473 RAN IN MODULE A S/N (B)(4) ORF1AB CT WAS 10.9, RFU AT THE 39 CYCLE WAS 97439.92, BUT AT THE 45 CYCLE WAS 112861.9, N GENE WAS NOT DETECTED, RNASE P CT WAS 28.6. RUN 2 NEGATIVE (M12V120287001-RUN#1467-B_20211223_102449) SAMPLE ID (B)(6) CASSETTE 1CVCAB4719220502A11410 RAN IN MODULE B S/N (B)(4) ORF1AB AND N GENE WERE NOT DETECTED, RNASE P CT WAS 27.0. ON (B)(6) 2021 QUESTION 2 "DID THE DEVICE MALFUNCTION, FAIL TO MEET ANY LABELED CLAIM, OR OTHERWISE FAIL TO PERFORM AS DESCRIBED IN ITS INTENDED USE?" WAS UPDATED TO 'YES' ONCE THE CUSTOMER PROVIDED DATA SHOWING THERE WAS A FALSE POSITIVE RESULT DUE TO ORF1AB EARLY CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999717 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB4719A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown