BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES® SARS-COV-2 ASSAY (EUA-IVD)

    MDR report key: 17015072 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00007
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    February 17, 2021
    Report Date
    May 26, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA200127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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. DURING A RETROSPECTIVE REVIEW OF LUMINEX CORPORATION COMPLAINT DATA, AS COMMITTED TO US FDA DURING THE CONTAINMENT OF OBSERVATION #2; FEI NUMBER: (B)(4) ISSUED ON 13 JANUARY 2023, THE FOLLOWING EVENT WAS IDENTIFIED TO BE A REPORTABLE EVENT FOR A FALSE RESULT ON AN EUA PRODUCT THAT WAS NOT PREVIOUSLY REPORTED. THIS REPORT IS ONE OF NINE IDENTIFIED EVENTS THAT WERE NOT ORIGINALLY REPORTED TO THE FDA AS REQUIRED.

    Description of Event or Problem · 0

    DURING A RETROSPECTIVE REVIEW OF LUMINEX CORPORATION COMPLAINT DATA, AS COMMITTED TO US FDA DURING THE CONTAINMENT OF OBSERVATION #2; FEI NUMBER: (B)(4)ISSUED ON 13 JANUARY 2023, THE FOLLOWING EVENT WAS IDENTIFIED TO BE A REPORTABLE EVENT FOR A FALSE RESULT ON AN EUA PRODUCT THAT WAS NOT PREVIOUSLY REPORTED. THIS REPORT IS ONE OF NINE IDENTIFIED EVENTS THAT WERE NOT ORIGINALLY REPORTED TO THE FDA AS REQUIRED. DATA REVIEW: ON 02/17/2021 CUSTOMER (B)(6) LABS CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT TWO FALSE NEGATIVE RESULTS FOR ARIES SARS-COV-2 EUA ASSAY PN: 50-10047 LOT: AB1608A HAD OCCURRED DURING SAMPLE ANALYSIS WHEN COMPARED TO THE RESULTS RECEIVED FROM THE CUSTOMER'S GENE XPERT TESTING. BOTH SAMPLES THAT WERE POSITIVE ON THE GENE XPERT YIELDED NEGATIVE RESULTS ON THE ARIES SARS-COV-2 ASSAY. CUSTOMER PROVIDED ARIES RUN DATA AND REPORTS FOR THE SAMPLE RUN: RUN#027-A_SAMPLE 4: SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = 39.7, RNASE P CT = 28.0. RUN#027-A_SAMPLE 5: SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = 39.4, RNASE P CT = 26.6. CONSUMABLE REVIEW: NO FALSE RESULTS WERE REPORTED DURING AQL TESTING OF LOT AB1608A ON 01/19/2021. ONE NCMR IS ASSOCIATED WITH THIS LOT DUE TO A LABELING ISSUE. THIS NCMR IS UNRELATED TO ASSAY PERFORMANCE. THERE IS ONE ADDITIONAL COMPLAINT CASE REPORTING A FALSE RESULT FOR LOT AB1608A WITHIN SALESFORCE AT THIS TIME. ADDITIONAL COMPLAINT CASE WAS PREVIOUSLY REPORTED AS MDR- 21-008. DEVICE REVIEW: ARIES SYSTEM SN: (B)(6). 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. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. CONCLUSION: THE ROOT CAUSE OF THE FALSE NEGATIVE RESULTS IS DUE TO DELAYED AMPLIFICATION SIGNALS FOR THE N TARGET FOR BOTH SAMPLES. THIS IS TYPICALLY DUE TO VIRAL CONCENTRATION WITHIN THE SAMPLE BEING BELOW THE LIMIT OF DETECTION FOR THE ARIES SARS-COV-2 ASSAY. THERE IS NO INDICATION OF A HARDWARE OR CONSUMABLE MALFUNCTION. THIS CASE WAS NOT ORIGINALLY IDENTIFIED AS MEETING THE REQUIREMENTS FOR MDR REPORTING. THIS COMPLAINT OF A FALSE RESULT ON THE EUA ARIES SARS-COV-2 ASSAY IS REQUIRED TO BE REPORTED AS AN MDR. (B)(4) WILL BE SUBMITTED AS AN MDR TO THE FDA TO FULFILL REPORTING REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670543 ARIES® SARS-COV-2 ASSAY (EUA-IVD) ARIES® SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB1608A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown