BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17015088 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00013
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    August 10, 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: 3002524000 - FORM 483 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: 3002524000 - FORM 483 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 THE CUSTOMER GENECRAFT LABS REPORTED TO LUMINEX TECHNICAL SUPPORT (TS) THAT THE ARIES SARS-COV2-EUA ASSAY PN:(B)(6) LOT:AB0803A YIELDED A FALSE POSITIVE RESULT. THE CUSTOMER PROVIDED DETAILED REPORTS OF THE DISCREPANT RESULT AS WELL AS THE REPEAT TESTING RESULTS. POSITIVE RESULT DATA: CASSETTE ID: (B)(4) RAN AT 03:57AM ON (B)(6) 2020, SAMPLE ID: (B)(6), THE ORF1AB GENE WAS DETECTED WITH CT OF 16.5. THE N GENE WAS NOT DETECTED. THE RNASEP GENE WAS ALSO NOT DETECTED. RESULT WAS SARSCOV-2 POSITIVE. NEGATIVE RESULT DATA: CASSETTE ID: (B)(4) RAN AT 10:18PM ON (B)(6)2020, SAMPLE ID: (B)(6), THE ORF1AB GENE WAS NOT DETECTED. THE N GENE WAS NOT DETECTED. THE RNASEP GENE WAS DETECTED WITH A CT OF 26.6. RESULT WAS SARS-COV-2 NEGATIVE. NEGATIVE RESULT DATA: CASSETTE ID: (B)(4) RAN AT 09:38AM ON (B)(6) 2020, SAMPLE ID: WILLIAM, THE ORF1AB GENE WAS NOT DETECTED. THE N GENE WAS NOT DETECTED. THE RNASEP GENE WAS DETECTED WITH A CT OF 32.2. RESULT WAS SARS-COV-2 NEGATIVE. CONSUMABLE REVIEW: THERE WERE NO FALSE POSITIVE RESULTS REPORTED DURING QC TESTING OF LOT AB0803A ON (B)(6)2020. THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. THERE ARE NO OTHER RELATED COMPLAINTS FOR FALSE POSITIVE RESULTS FOR LOT AB0803A REPORTED. THERE IS NO EVIDENCE OF A CONSUMABLE MALFUNCTION. 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. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. SAMPLE WORK-UP: THE SAMPLE WORK-UP IS CONFIRMED TO BE CONSISTENT WITH THE PACKAGE INSERT. CONCLUSION: THE ROOT CAUSE OF THE FALSE POSITIVE 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
    1915478 ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB0803A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown