BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 15685491 · Received October 27, 2022

    Report

    Report Number
    1650733-2022-00054
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    September 28, 2022
    Report Date
    October 27, 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) CONFIRMED THE POTENTIAL FOR A PRODUCT DEFECT TO BE PRESENT IN LOT AB6640A, WHICH COULD LEAD TO FALSE NEGATIVE RESULTS. COMPLAINT CASE (B)(4) DOES NOT PROVIDE EVIDENCE THAT A PRODUCT DEFECT WAS PRESENT AT THE TIME OF THE REPORTED FALSE RESULT. 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 MEET THE REQUIREMENTS FOR AN MDR. 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 CALLED TO REPORT DISCREPANT RESULTS OBSERVED WHEN TRYING TO VALIDATE NEW LOT OF SARS COV-2 ASSAY (AB6640). CUSTOMER RAN POS AND NEG QC ASSAYS TWICE TODAY AND KEPT REPORTING 'NOT DETECTED' DISCREPANT RESULTS. NO PATIENT SAMPLES HAVE BEEN RUN YET. ASSAYS WERE RUN ON BOTH MODULES OF INSTRUMENT WITH IDENTICAL RESULTS. CUSTOMER USING SERACARE CONTROLS AND CONFIRMED QC LOT HAS BEEN INVESTIGATED PREVIOUSLY AND HAS BEEN SUCCESSFUL ON OTHER ASSAYS SO IT SHOULD NOT BE THE ISSUE. SARS COV-2 KIT LOT AB6640 RECEIVED 08/19/2022. DATA REVIEW: ON (B)(6) 2022, CUSTOMER (B)(6) CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT A POTENTIAL FALSE NEGATIVE RESULT FOR ARIES SARS-COV2-EUA ASSAY, PN: 50-10047. CUSTOMER PROVIDED ARIES SYSTEM SUPPORT UTILITY FILE AND RUN FILES FOR THE DISCREPANT RUNS INDICATE LOT AB6640A WAS THE LOT UTILIZED. CUSTOMER REPORTED USING SERACARE POSITIVE AND NEGATIVE CONTROL SAMPLES. PREVIOUS LOTS OF 50-10047 PASSED CUSTOMER QC USING THIS SAME CONTROL MATERIAL. CONSUMABLE REVIEW: NO FALSE NEGATIVE RESULTS WERE REPORTED DURING AQL TESTING OF LOT AB6640A ON 06/20/2022. NCMR (B)(4) WAS ASSIGNED TO LOT AB6640A FOR A DOCUMENTATION ERROR THAT HAS NO IMPACT ON FINAL PRODUCT. THERE ARE NO ADDITIONAL COMPLAINT CASES FOR FALSE RESULTS FOR LOT AB6640A REPORTED IN SALESFORCE. 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: CUSTOMER STATES POSITIVE QC SAMPLE RETURNED NEGATIVE RESULTS. CONCLUSION: THERE IS NO INDICATION OF AN ARIES HARDWARE MALFUNCTION. THE ROOT CAUSE OF THE FALSE NEGATIVE RESULT OCCURRING ON LOT AB6640A COULD POTENTIALLY BE DUE TO A CONSUMABLE MALFUNCTION BEING INVESTIGATED UNDER ESCALATION CASE (B)(4) AND CAPA-00258. IT IS NOT POSSIBLE TO CONFIRM THE DEFECT WAS PRESENT ON THE CASSETTE THAT YIELDED A FALSE NEGATIVE QC SAMPLE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2802493 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB6640A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown