BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD

    MDR report key: 16279762 · Received February 1, 2023

    Report

    Report Number
    1650733-2023-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    March 8, 2022
    Report Date
    February 1, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA200127
    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 LIGHT OF THE COVID-19 PANDEMIC AND THE SUBSEQUENT AUTHORIZATIONS (EUAS) FOR SARS-COV-2 DIAGNOSTICS TESTS AND PER THE CONDITIONS OF THE EMERGENCY USE AUTHORIZATION, SUSPECTED FALSE NEGATIVES, FALSE POSITIVES AND SIGNIFICANT DEVIATIONS IN EXPECTED PERFORMANCE CHARACTERISTICS WILL BE REPORTED UNDER 21 CFR 803. THE ALLEGED FALSE TEST RESULTS IN THIS EVENT HAVE NOT CAUSED PATIENT INJURY OR DEATH; HOWEVER, THIS EVENT IS BEING REPORTED CONSERVATIVELY BECAUSE IF THE ALLEGED MALFUNCTION WERE TO RECUR THERE IS A NON-REMOTE POTENTIAL FOR SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: CUSTOMER REPORTED TWO INSTANCES OF FALSE POSITIVE RESULTS FOR ARIES SARS-COV2-EUA HAD OCCURRED WHILE RUNNING A 3RD PARTY NEGATIVE CONTROL SAMPLE. DATA REVIEW: ON (B)(6) 2022, CUSTOMER MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT TWO INSTANCES OF FALSE POSITIVE RESULTS FOR ARIES SARS-COV2-EUA ASSAY PN: 50-10047 LOT: AB5339A HAD OCCURRED WHILE RUNNING A 3RD PARTY NEGATIVE CONTROL SAMPLE. CUSTOMER PROVIDED RUN FILES SHOW CONFIRMATION OF UNEXPECTED RESULTS FOR 2 OF THE 2 NEGATIVE QUALITY CONTROL ASSAY RUNS YIELDING POSITIVE SARS-COV-2 RESULTS. QC SAMPLE ID SARS-COV2 NEGATIVE CONTROL NATSARS (COV2)-NEG RUN NAME M12V120157001_3817792-12_20220225_084816 CASSETTE ID: 1CVCAB5339221020A02966. RESULT: SARS-COV-2 POSITIVE, ORF1AB GENE NOT DETECTED, N-GENE DETECTED AT CT 38.1, RNASE P DETECTED AT CT 28.6. QC SAMPLE ID SARS-COV2 NEGATIVE CONTROL NATSARS (COV2)-NEG RUN NAME M12V120157001_3818052-12_20220225_084815 CASSETTE ID: 1CVCAB5339221020A02855. RESULT: SARS-COV-2 POSITIVE, ORF1AB GENE NOT DETECTED, N-GENE DETECTED AT CT 37.5, RNASE P DETECTED AT CT 29.3. CONSUMABLE REVIEW: NO FALSE RESULTS WERE REPORTED DURING AQL TESTING OF LOT: AB5339A ON (B)(6) 2022. THERE IS ONE NCMR ASSOCIATED WITH THIS LOT FOR A DOCUMENTATION ERROR. THERE ARE FOUR ADDITIONAL COMPLAINT CASES FOR LOT: AB5339A ALL REPORTED BY THIS SAME CUSTOMER WITHIN SALESFORCE AT THIS TIME. DEVICE REVIEW: ARIES SYSTEM SN: (B)(4), MODULE 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 NOR MODULE DURING THE PRIOR 6 MONTHS THAT WOULD CONTRIBUTE TO FALSE RESULTS. SAMPLE WORK-UP: CONFIRMATION THAT THE SAMPLE WORK-UP WAS PERFORMED CONSISTENT WITH THE PACKAGE INSERT INSTRUCTION WAS PROVIDED BY THE CUSTOMER. SAMPLE BEING TESTED WAS A 3RD PARTY QC SAMPLE. NO PATIENT SAMPLES WERE REPORTED TO HAVE FALSE RESULTS. CONCLUSION: THE ROOT CAUSE OF THE FALSE POSITIVE RESULTS CANNOT BE DETERMINED. THERE ARE NO NCMR'S ASSOCIATED WITH THE LOT UTILIZED. THERE IS NO INDICATION OF CONSUMABLE OR HARDWARE MALFUNCTION. ESCALATION CASE: (B)(4) PREVIOUSLY INVESTIGATED THE OCCURRENCE OF FALSE POSITIVE RESULTS. IT WAS DETERMINED THAT WHILE A FALSE POSITIVE RESULT IS POSSIBLE, THE LIMITATIONS SECTION OF ARIES SARS-COV-2 PACKAGE INSERT, 89-30000-00-865, ESTABLISHES THAT 'THE RESULTS OF THIS TEST SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER PATIENT MANAGEMENT DECISIONS.' THE RISK WAS ASSESSED ON RA-LMNX-20-0161 AND DETERMINED TO BE LOW RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300474 ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB5339A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown