BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES® SARS-COV-2 ASSAY (EUA-IVD)

    MDR report key: 17015073 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00009
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    September 23, 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
    ME, 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. 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 09/23/2020 CUSTOMER (B)(6) MEDICAL CENTER CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT THE POSITIVE QC MATERIAL THEY WERE USING WAS NOT IDENTIFYING ALL POSITIVE TARGETS FOR ARIES SARS-COV-2 EUA ASSAY PN: 50-10047 LOTS AB0984A AND AB1025A. CUSTOMER IS USING SERACARE BRAND POSITIVE QC CONTROL MATERIAL. ONE QC RUN FOR EACH ASSAY RESULTED IN ONE TARGET NOT BEING IDENTIFIED. IN BOTH INSTANCES THE ASSAY MADE A POSITIVE CALL FOR THE POSITIVE CONTROL MATERIAL. RUN DATA FOR THE TWO REPORTED MISSED TARGETS IS: CASSETTE: 1CVCAB1025201128A01067, SAMPLE ID: POS QC ARIES 1 10512247 EXP 8-10-22, RAN 08/03/2020 RAN IN SLOT A1 (MD18155001). RESULT WAS SARS-COV-2 POSITIVE; SARS-COV-2 - ORF1AB CT 37.4, SARS-COV-2 - N WAS ND. THE RNASE P (SPC) WAS ND. CASSETTE: (B)(6), SAMPLE ID: POS QC ARIES 1 10512247 EXP 8-10-22, RAN 08/03/2020 RAN IN SLOT A1 (MD18155001). RESULT WAS SARS-COV-2 POSITIVE; SARS-COV-2 - ORF1AB ND, SARS-COV-2 - N CT 37.5. THE RNASE P (SPC) WAS ND. CUSTOMER REPEATED SERACARE CONTROL ON CASSETTE: (B)(6), SAMPLE ID: POSITIVE. (B)(6), RAN 08/03/2020 RAN IN SLOT 5 (MD18155001). RESULT WAS SARS-COV-2 POSITIVE; SARS-COV-2 - ORF1AB CT 33.0, SARS-COV- 2 - N CT 34.3. THE RNASE P (SPC) WAS ND. CONSUMABLE REVIEW: NO FALSE RESULTS OR MISSED TARGETS WERE REPORTED DURING AQL TESTING OF LOT AB0984A ON 08/16/2020. NO FALSE RESULTS OR MISSED TARGETS WERE REPORTED DURING AQL TESTING OF LOT AB1025A ON 08/21/2020. NO NCMRS ARE ASSOCIATED WITH LOT AB1025A OR LOT AB0984A. THERE ARE TWO ADDITIONAL COMPLAINT CASES RELATED TO FALSE RESULTS FOR LOT AB1025A AND NO ADDITIONAL COMPLAINT CASES RELATED TO FALSE RESULTS FOR LOT AB0984A WITHIN SALESFORCE 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. 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 FAILURE TO IDENTIFY BOTH POSITIVE TARGETS CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE ARIES SARS-COV-2 ASSAY ONLY REQUIRES THE DETECTION OF ONE TARGET, ORF1AB OR N, TO MAKE A POSITIVE CALL. IN BOTH RESULTS THE CUSTOMER HAS IDENTIFIED, THE ASSAY MADE THE CORRECT CALL. THERE IS NO INDICATION OF CONSUMABLE OR HARDWARE MALFUNCTION. SERACARE CONTROLS WERE NOT USED IN THE VALIDATION OF THIS ASSAY, AND THERE ARE KNOWN DIFFICULTIES REPORTED WITHIN SALESFORCE WHEN USING THE SERACARE BRAND OF SARS POSITIVE CONTROL MATERIAL TO QC ARIES SARS-COV-2 EUA ASSAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670544 ARIES® SARS-COV-2 ASSAY (EUA-IVD) ARIES® SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB0984A, AB1025A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown