BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17015089 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00014
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    June 1, 2020
    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. ON 06/01/2020 CUSTOMER (B)(6) CONTACTED LUMINEX TECHNICAL SUPPORT (TS) REPORTING FALSE NEGATIVE DATA ON THE ARIES SARS-COV2-EUA ASSAY, PN: 50-10047. CUSTOMER PROVIDED ARIES SYSTEM SUPPORT UTILITY FILE AND RUN FILES FOR THE DISCREPANT RUNS WHICH INDICATE THAT LOT AB0586A WAS THE CASSETTE LOT UTILIZED. CUSTOMER STATED A DISAGREEMENT BETWEEN SANSURE'S NOVEL CORONAVIRUS (2019-NCOV) NUCLEIC ACID DIAGNOSTIC KIT (EUA) RESULTS AND THE ARIES RESULTS. SAMPLE/RAW DATA ANALYSIS CANNOT BE PERFORMED FOR SINCE THE FALSE NEGATIVE CALLS CANNOT BE CONFIRMED FROM THE DATA PROVIDED. PER THE ARIES SARS-COV-2 PACKAGE INSERT, A VALID NEGATIVE RESULT WILL OCCUR IF NEITHER THE ORF1AB GENE NOR THE N GENE TARGETS ARE DETECTED WHILE THE RNASE P IS DETECTED. A VALID POSITIVE RESULT WILL OCCUR IF EITHER THE ORF1AB GENE OR THE N GENE (OR BOTH) ARE DETECTED WHILE RNASE MAY OR MAY NOT BE DETECTED. CONSUMABLE REVIEW: NO FALSE NEGATIVE RESULTS WERE REPORTED DURING QC TESTING OF LOT AB0586A ON 04/25/2020. THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. THERE ARE TWO OTHER CASES REPORTING FALSE NEGATIVE RESULTS FOR LOT AB0586A IN (B)(4) AT THIS TIME (CASES (B)(4)). 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 A FALSE RESULT. SAMPLE WORK-UP: SAMPLES WERE KEPT AT 4C (LESS THAN 5 DAYS OLD) AND ANALYZED USING SANSURE'S NOVEL CORONAVIRUS (2019-NCOV) NUCLEIC ACID DIAGNOSTIC KIT (EUA) ON (B)(6) 2020. ALL SAMPLES WERE ANALYZED ON THE ARIES ON (B)(6). SAMPLE TYPE WAS NPS. CONCLUSION: THE ROOT CAUSE OF THE FALSE NEGATIVE CANNOT BE DETERMINED. THERE ARE NO NCMRS ASSOCIATED WITH THE LOT UTILIZED. 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
    1915479 ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB0586A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown