BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 15237649 · Received August 16, 2022

    Report

    Report Number
    1650733-2022-00047
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    May 17, 2022
    Report Date
    August 16, 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 (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

    CUSTOMER REPORTING A PATIENT SAMPLE PRODUCED A FALSE POSITIVE RESULT WHILE USING THE SARS-COV-2 ASSAY, ARIES RUN 1: SARS-COV-2 POSITIVE, AREIS RUN 2: SARS-COV-2 NEGATIVE. DATA REVIEW: ON (B)(6) 2022 CUSTOMER (B)(6) CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT A POTENTIAL FALSE POSITIVE RESULT FOR ARIES SARS-COV2-EUA ASSAY, PN: 50-10047. CUSTOMER REFUSED TO PROVIDE ARIES SYSTEM SUPPORT UTILITY FILE AND RUN FILES FOR THE DISCREPANT RUNS. CUSTOMER TESTED THE SAME PATIENT SAMPLE TWICE: ARIES RUN 1: SARS-COV-2 POSITIVE, AREIS RUN 2: SARS-COV-2 NEGATIVE. CONSUMABLE REVIEW: LUMINEX TECHNICAL SUPPORT REQUESTED LOT INFORMATION FOR THE ARIES SARS-COV2-EUA ASSAY USED, BUT CUSTOMER DID NOT PROVIDE THE LOT NUMBER USED. DEVICE REVIEW: ARIES SYSTEM SN: (B)(4). REVIEW OF THE UTILIZED DEVICE'S HISTORY WAS ACCESSED FOR A PERIOD OF 6 MONTHS PRIOR TO THE REPORTED DISCREPANT RESULT. THERE WERE NO SERVICE ACTIONS FOR THE ARIES SYSTEM DURING THE PRIOR 6 MONTHS THAT WOULD CONTRIBUTE TO A FALSE RESULT. SAMPLE WORK-UP: CONFIRMATION THAT THE SAMPLE WORK-UP WAS PERFORMED CONSISTENT WITH THE PACKAGE INSERT INSTRUCTION WAS PROVIDED BY THE CUSTOMER. CUSTOMER STATES THE SAME PATIENT SAMPLE WAS USED FOR BOTH TEST EVENTS. CONCLUSION: THE ROOT CAUSE OF THE SUSPECTED FALSE RESULT CANNOT BE DETERMINED. THERE IS NO INDICATION OF A HARDWARE MALFUNCTION. THE LACK OF ARIES RUN FILES OR ADDITIONAL DATA FROM THE CUSTOMER IMPEDES FURTHER INVESTIGATION. WITHOUT ADDITIONAL INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHICH RESULT WAS THE FALSE RESULT. CUSTOMER INFORMED LUMINEX ON 8/11/2022 THAT THEY DO NOT WANT TO PURSUE ANY FURTHER ACTION ON THIS COMPLAINT CASE AND REQUESTED THE CASE BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1950808 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION NOT PROVIDED BY CUSTOMER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown