BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 16091847 · Received January 3, 2023

    Report

    Report Number
    1650733-2022-00063
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    November 5, 2022
    Report Date
    January 3, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL CASE DETAILS AGAINST THE CRITERIA SET FORTH IN DOCUMENT 00043 (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE) AND ITS APPLICABLE APPENDICES, THIS COMPLAINT DOES MEET THE REQUIREMENTS FOR AN MDR. 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.

    Description of Event or Problem · 0

    THE CUSTOMER STATED BY EMAIL ON 11/9/2022 PER CASE (B)(4) THAT THEY RECEIVED A DISCREPANT RESULT FOR PATIENT SAMPLE ID (B)(6) WITH ARIES SARS-COV-2 LOT AB7259A COMPARED TO RUN 2 RAN WITH ARIES SARS-COV-2 LOT UNKNOWN. CUSTOMER REPORTING THIS HAS OCCURRED ON MORE THAN ONE OCCASION, BUT ONLY PROVIDED DATA FOR MOST RECENT SAMPLE. CUSTOMER STATED THAT ONLY ONE OF THE GENES ORF WAS POSITIVE WITH CT VALUES UNDER 30 OR 20 AND OTHER GENE N WILL BE ND (NOT DETECTED) BUT THE RESULT WILL FLAG AS POSITIVE. CUSTOMER REPEATING THESE SAMPLES EITHER IN ARIES OR CEPHEID AND THEY WILL COME OUT NEGATIVE. DATA REVIEW: ON 11/09/2022 CUSTOMER RADIANCE BIOSCIENCES & CONSULTANCY LLC CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT A DISCREPANT FALSE POSITIVE RESULT FOR ARIES SARS-COV2-EUA ASSAY PN:50-10047 LOT:AB7259A. POSITIVE RESULT CONFIRMED IN THE RUN FILE PROVIDED BY THE CUSTOMER, HOWEVER, DATA FROM REPEAT TESTS THAT WERE CONFIRMED EITHER IN ARIES OR CEPHEID HAVE NOT BEEN PROVIDED. POSITIVE RESULT DATA: CASSETTE ID: (B)(4) RAN AT 08:38 ON (B)(6) 2022, SAMPLE ID: (B)(6), THE ORF1AB GENE WAS DETECTED WITH A CT OF 27.1 WHILE THE N GENE AND RNASEP WERE NOT DETECTED. RESULT WAS SARS-COV-2 POSITIVE. CONSUMABLE REVIEW: THERE WAS ONE FALSE POSITIVE RESULT REPORTED DURING AQL TESTING OF LOT AB7259A ON (B)6) 2022. THE N GENE WAS DETECTED BY CASSETTE SN (B)(4), THE ORF1AB GENE WAS NOT DETECTED. THE POSITIVE TEST RESULT BY THAT CASSETTE MET AQL ACCEPTANCE CRITERIA OF LESS THAN OR EQUAL TO 2 N GENES ALLOWABLE TO PASS THE LOT. THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. THERE ARE NO OTHER RELATED COMPLAINTS FOR FALSE POSITIVE RESULTS FOR LOT AB7259A CURRENTLY REPORTED. THERE IS NO EVIDENCE OF A CONSUMABLE MALFUNCTION. DEVICE REVIEW: ARIES SYSTEM SN: (B)(4), MODULE A SN:(B)(4), MODULE B SN: UNKNOWN. REVIEW OF THE UTILIZED DEVICE'S HISTORY FOR EACH THE SYSTEM AND MODULE A WAS ACCESSED FOR A PERIOD OF 6 MONTHS PRIOR TO THE REPORTED DISCREPANT RESULT. THERE ARE NO COMPLAINTS FOR ARIES SYSTEM (B)(4) AND NO COMPLAINTS FOR MODULE A SN:(B)(4). 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 FALSE POSITIVE CANNOT BE DETERMINED. THERE ARE NO NCMRS ASSOCIATED WITH THE LOT UTILIZED. THERE IS NO INDICATION OF CONSUMABLE OR HARDWARE MALFUNCTION. ESCALATION CASE (B)(4) PREVIOUSLY INVESTIGATED THE OCCURRENCE OF FALSE POSITIVE RESULTS. IT WAS DETERMINED THAT WHILE A FALSE POSITIVE RESULT IS POSSIBLE, THE LIMITATIONS SECTION OF ARIES SARS-COV-2 PACKAGE INSERT, 89-30000-00-865, ESTABLISHES THAT 'THE RESULTS OF THIS TEST SHOULD NOT BE USED AS THE SOLE BASIS FOR DIAGNOSIS, TREATMENT, OR OTHER PATIENT MANAGEMENT DECISIONS.' THE RISK WAS ASSESSED ON RA-LMNX-20-0161 AND DETERMINED TO BE LOW RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653177 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB7259A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown