BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14089699 · Received April 12, 2022

    Report

    Report Number
    1650733-2022-00005
    Event Type
    Malfunction
    Date Received
    April 12, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 12, 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 (B)(6) 2022: THE CUSTOMER REPORTED MULTIPLE SARS-COV-2 FALSE POSITIVES. ARIES RUN 1 SARS-COV-2 POSITIVE. ARIES RUN 2 SARS-COV-2 NEGATIVE. PANTHER RUN: NEGATIVE. DATA REVIEW: 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: SAMPLE ID (B)(6), RUN NAME (B)(4), CASSETTE ID: 1CVCAB5339221020A03115 INSTRUMENT S/N (B)(4) MODULE S/N (B)(4) SLOT A2 CASSETTE LOT: AB5339A. RESULT: SARS-COV-2 POSITIVE ORF1AB GENE NOT DETECTED, N-GENE DETECTED AT CT 36.2, RNASE P DETECTED AT 31.5 RUN 2: SAMPLE ID (B)(6) RUN NAME (B)(4) CASSETTE ID: 1CVCAB5339221020A04654 INSTRUMENT S/N (B)(4) MODULE S/N (B)(4) SLOT B1, CASSETTE LOT: AB5339A. RESULT: SARS-COV-2 NEGATIVE ORF1AB GENE NOT DETECTED, N-GENE NOT DETECTED, RNASE P DETECTED AT 31.2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186062 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB5339A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown