BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 15635178 · Received October 19, 2022

    Report

    Report Number
    1650733-2022-00051
    Event Type
    Malfunction
    Date Received
    October 19, 2022
    Date of Event
    February 15, 2022
    Report Date
    October 18, 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

    (B)(4) WAS APPROVED TO FACILITATE THE RETURN OF ASSAY CASSETTES FROM THE CUSTOMER SITE BACK TO LUMINEX FOR FURTHER INVESTIGATION. AT THE TIME OF REMOVAL, THERE WERE NO ASSOCIATED RISKS AS THE ROOT CAUSE OF FAILURE HAS NOT YET BEEN DETERMINED. LOT AB5139A OF ARIES SARS-COV-2 ASSAY PN:50-10047 WAS DETERMINED DEFECTIVE AND A CLASS II RECALL WAS WARRANTED DUE TO THE RISK OF FALSE NEGATIVE TEST RESULTS. 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 (B)(6) 2022 THE CUSTOMER REPORTED MULTIPLE INVALIDS. THE CUSTOMER ALSO REPORTED A BLACK RESIDUE IN ONE OF THE CHAMBERS CLOSEST TO THE PCR TUBE ON SUCCESSFUL RUNS, BUT RUNS WHERE AN INVALID IS OBSERVED, THERE IS NO RESIDUE PRESENT. THIS HAS OCCURRED IN AT LEAST 5 OR 6 INVALIDS IN THE LAST APPROXIMATELY 60 CASSETTES. THIS ISSUE IS OCCURRING IN MODULES ON BOTH ARIES INSTRUMENTS. THE CUSTOMER NOTED THAT RETESTING DOES RESULT IN VALID RESULTS SOME OF THE TIME. IMAGES OF THE CASSETTES SHOW LACK OF TRANSFER OF MAGNETIC PARTICLES. THE CUSTOMER WILL BE RETURNING 7 UNUSED KITS TO LUMINEX FOR INVESTIGATION PURPOSES PER (B)(4). DATA REVIEW: ON 02/15/2022 (B)(6) CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT AN INCREASE IN INVALID RESULTS OCCURRING WHEN USING LOT AB5139A OF ARIES SARS-COV-2 ASSAY PN: 50-10047. CUSTOMER PROVIDED PHOTOGRAPH SHOWS THREE CASSETTES THAT RETURNED INVALID RESULTS. THE FAILURE TO TRANSFER MAGNETIC PARTICLES BEYOND THE FIRST WASH CHAMBER CAN BE SEEN IN THESE THREE CASSETTES. CUSTOMER STATES THIS ISSUE HAPPENED ON BOTH MODULES OF THE ARIES SYSTEM. CONSUMABLE REVIEW: NO INVALID RESULTS WERE REPORTED DURING AQL TESTING OF LOT AB5139A ON 12/19/2021. THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. THERE ARE NO ADDITIONAL COMPLAINT CASES REPORTING INVALIDS FOR LOT AB5139A REPORTED IN SALESFORCE AT THIS TIME. (B)(4) WAS APPROVED TO FACILITATE THE RETURN OF ASSAY CASSETTES FROM THE CUSTOMER SITE BACK TO LUMINEX FOR FURTHER INVESTIGATION. AT THE TIME OF REMOVAL, THERE WERE NO ASSOCIATED RISKS AS THE ROOT CAUSE OF FAILURE HAS NOT YET BEEN DETERMINED. LOT AB5139A WAS RECALLED ON RC-22-011 DUE TO A POTENTIAL PRODUCT DEFECT THAT COULD LEAD TO INVALID OR FALSE NEGATIVE TEST RESULTS. 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 INVALID RESULTS. THERE ARE NO COMPLAINTS FOR ARIES SYSTEM (B)(4) THAT INDICATE A DEVICE MALFUNCTION THAT WOULD LEAD TO REOCCURRING INVALID RESULTS. SAMPLE WORK-UP: CUSTOMER SAMPLE WORK-UP INFORMATION WAS NOT CAPTURED IN THIS CASE. CONCLUSION: THE ROOT CAUSE OF THE INVALID RESULTS FOR LOT AB5139A WHERE THE FAILURE TO TRANSFER MAGNETIC PARTICLES THROUGH THE CASSETTE HAS BEEN DETERMINED TO BE DUE TO A CONSUMABLE MALFUNCTION WHICH WAS INVESTIGATED UNDER ESCALATION CASE (B)(4) AND CAPA-(B)(4). A CLASS II RECALL WAS DETERMINED AS NECESSARY FOR LOT AB5139A ON RC-22-011. CAN-0307 WAS RELEASED AND DISTRIBUTED TO CUSTOMERS TO PROVIDE NOTIFICATION OF THE RISK ASSOCIATED WITH THIS PRODUCT DEFECT. (B)(4) ORIGINALLY DETERMINED THIS EVENT AS NOT REPORTABLE, BUT AFTER COMPLETION OF THE RECALL INVESTIGATION AND DISTRIBUTION OF A CLASS II RECALL FOR LOT AB5139A, A NEW ASSESSMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175544 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB5139A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown