BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 12863593 · Received November 23, 2021

    Report

    Report Number
    1650733-2021-00021
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    November 3, 2021
    Report Date
    November 23, 2021
    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 (B)(4)(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 11/05/2021: LUMINEX MAS REPORTED ON BEHALF OF CUSTOMER 3 SUSPECTED FALSE NEGATIVES ON 3 DIFFERENT PATIENT SAMPLES WHILE UTILIZING THE ARIES SARS-COV-2 ASSAY. (B)(6). CASE (B)(4)(PATIENT ID (B)(6)): CASSETTE (B)(4) RAN AT 14:48 ON (B)(6) 2021 IN SLOT B OF ARIES SN (B)(4), MODULE SN (B)(4). THE RESULTS SHOW THE SAMPLE WAS NEGATIVE FOR THE ORF1AB GENE AND NEGATIVE FOR N GENE, RNASE P WAS DETECTED AT 28 CT. CASSETTE (B)(4) RAN ON (B)(6) 2021 IN SLOT A1 OF ARIES SN (B)(4), MODULE SN (B)(4). THE ARIES RESULT WAS NEGATIVE FOR SARS-COV-2. THE RESULTS SHOW THE SAMPLE WAS NEGATIVE FOR THE ORF1AB GENE AND NEGATIVE FOR N GENE, RNASE P WAS DETECTED AT 25.3 CT. CASE (B)(4) (PATIENT ID (B)(6)): CASSETTE (B)(4) RAN AT 16:28 ON (B)(6) 2021 IN SLOT B2 OF ARIES SN (B)(4), MODULE SN (B)(4). THE RESULTS SHOW THE SAMPLE WAS NEGATIVE FOR THE ORF1AB GENE AND NEGATIVE FOR N GENE, RNASE P WAS DETECTED AT 25.2 CT. THIS SAMPLE WAS NOT SHOWN TO BE REPEATED ON THE ARIES FOR CONFIRMATION TESTING. CASE (B)(4) (PATIENT ID (B)(6)): CUSTOMER REPORTS THE PATIENT SAMPLE WAS RAN ON AN ARIES SYSTEM AND RESULTS WERE NEGATIVE FOR SARS-COV. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. CASSETTE (B)(4) RAN AT 16:28 ON (B)(6) 2021 IN SLOT B3 OF ARIES SN (B)(4), MODULE SN (B)(4). THE SAMPLE ANALYSIS SHOWED POSITIVE FOR THE N GENE WITH A CT VALUE OF 28.2 AND THE RNASE P GENE POSITIVE WITH A CT VALUE OF 26.7. THERE WAS NO ORF1AB GENE TARGET DETECTED. THE ARIES RESULTS WERE REPORTED TO THE MEDICAL TEAM. THE LAB DOES NOT KNOW IF THERE WAS ANY CHANGE IN THERAPY OR ADVERSE EVENT TO THE PATIENT BASED ON ARIES RESULTS. CUSTOMER REPORTS THAT THE SAMPLES TESTED POSITIVE ON THE HOLOGIC PANTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764130 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB4385A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown