BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY (EUA-IVD)

    MDR report key: 16598675 · Received March 23, 2023

    Report

    Report Number
    1650733-2023-00004
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    March 13, 2023
    Report Date
    March 23, 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

    DATA REVIEW: ON (B)(6), 2023 CUSTOMER ACL: OLEAN CONTACTED LUMINEX TO REPORT MULTIPLE INSTANCES OF DISCREPANT RESULTS FOR ARIES SARS-COV2-EUA ASSAY PN:50-10047 LOT:AB8021 HAD OCCURRED WHEN COMPARING SAMPLE ANALYSIS RESULTS TO QUIDEL QUICKVUE SARS ANTIGEN TEST RESULTS. CUSTOMER CLAIMS THAT FOUR SAMPLES YIELDED NEGATIVE RESULTS ON THE ARIES ASSAY, BUT RETURNED POSITIVE RESULTS ON THE QUIDEL QUICKVUE SARS ANTIGEN TEST. CUSTOMER PROVIDED ARIES DETAILED REPORTS CONFIRM THE CUSTOMER RECEIVED 4 NEGATIVE SARS-COV-2 RESULTS. DETAILED REPORT ATTACHMENT CONTAINS SIX PAGES OF RESULTS, OUR UNIQUE NEGATIVE RESULT REPORTS, ONE DUPLICATE NEGATIVE RESULT REPORT, AND ONE POSITIVE RESULT REPORT. RUN#3270-A: SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = ND, RNASE P CT = 25.0 RUN#3291-B: SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = ND, RNASE P CT = 27.8 RUN#3273-B: SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = ND, RNASE P CT = 24.5 RUN#3272-A: SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = ND, RNASE P CT = 30.7 CONSUMABLE REVIEW: NO FALSE RESULTS WERE REPORTED DURING AQL TESTING OF LOT AB8021 ON 11/06/2022. NO NCMRS ARE ASSOCIATED WITH THIS LOT. THERE ARE NO ADDITIONAL COMPLAINT CASES FOR LOT AB8021 WITHIN SALESFORCE AT THIS TIME. 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 FALSE RESULTS. SAMPLE WORK-UP: CONFIRMATION THAT THE SAMPLE WORK-UP WAS PERFORMED CONSISTENT WITH THE PACKAGE INSERT INSTRUCTION WAS PROVIDED BY THE CUSTOMER. CONCLUSION: THE ROOT CAUSE OF THE ALLEGED FALSE NEGATIVE RESULTS CANNOT BE DETERMINED. THERE ARE NO NCMRS ASSOCIATED WITH THE LOT UTILIZED. THERE IS NO INDICATION OF CONSUMABLE OR HARDWARE MALFUNCTION. SAMPLES TESTED ON THE QUIDEL QUICKVUE SYSTEM WERE COMPLETED AT A DIFFERENT HOSPITAL SITE USING UNIQUE PATIENT SAMPLES THAT WERE COLLECTED ON THE SAME DAY AS THE ARIES SAMPLES. ARIES PCR RESULTS ARE BETTER SUITED TO DETECT CURRENT SARS-COV-2 INFECTIONS THAN ANTIGEN TEST KITS. FDA GUIDANCE STATES "ANTIBODY TESTS SHOULD NOT BE USED TO DIAGNOSE A CURRENT SARS-COV-2 INFECTION OR COVID-19" PER THE FDA WEBSITE. THE ARIES NEGATIVE RESULTS ARE TO BE CONSIDERED THE CORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420286 ARIES SARS-COV-2 ASSAY (EUA-IVD) ARIES® SARS-COV-2 ASSAY (EUA-IVD) QJR LUMINEX CORPORATION AB8021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown