BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES® SARS-COV-2 ASSAY (EUA-IVD)

    MDR report key: 17015071 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00008
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    January 5, 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 (B)(6) 2021 CUSTOMER (B)(6) LABS CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT A FALSE POSITIVE RESULT FOR ARIES SARS-COV-2 EUA ASSAY PN: 50-10047 LOT: AB1378A HAD OCCURRED DURING SAMPLE ANALYSIS. CUSTOMER RERAN THE SAMPLE IN DUPLICATE USING THE SAME ARIES SYSTEM AND ASSAY LOT AND BOTH SAMPLES YIELDED NEGATIVE RESULTS ON RETEST. CUSTOMER PROVIDED ARIES RUN DATA AND REPORTS FOR THE SAMPLE RUNS: POSITIVE - RUN#1131-B, SAMPLEID: (B)(6) : SARS-COV-2 - ORF1AB CT = 14.5, SARS-COV-2 N CT = ND, RNASE P, CT = 28.4. NEGATIVE - RUN#1131-B, SAMPLEID: (B)(6) : SARS-COV-2 - ORF1AB CT = ND, SARS-COV-2 N CT = ND, RNASE P, CT = 29.0. SECOND NEGATIVE RUN DATA WAS NOT PROVIDED. CONSUMABLE REVIEW: NO FALSE RESULTS WERE REPORTED DURING AQL TESTING OF LOT AB1378A ON 12/07/2020. TWO NCMRS ARE ASSOCIATED WITH THIS LOT, BOTH FOR DOCUMENTATION ERRORS UNRELATED TO PRODUCT PERFORMANCE. THERE ARE NO ADDITIONAL COMPLAINT CASES RELATED TO FALSE RESULTS FOR LOT AB1378A WITHIN (B)(4) AT THIS TIME. 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 ALLEGED FALSE POSITIVE CANNOT BE DETERMINED. THERE IS NO INDICATION OF CONSUMABLE OR HARDWARE 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
    1670542 ARIES® SARS-COV-2 ASSAY (EUA-IVD) ARIES® SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB1378A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown