BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 12707910 · Received October 27, 2021

    Report

    Report Number
    1650733-2021-00017
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 9, 2021
    Report Date
    October 26, 2021
    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

    DATA REVIEW: ON 10/12/2021 THE CUSTOMER CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT A DISCREPANT FALSE POSITIVE RESULT FOR ARIES SARS-COV2-EUA ASSAY PN: 50-10047 LOT: AB4200. PROVIDED RUN FILES SHOW INITIAL RUN AS A POSITIVE, WHILE REPEAT RUN YIELDED A NEGATIVE RESULT: CASSETTE ID: (B)(6) RAN AT 2:02 PM ON (B)(6) 2021, SAMPLE ID: (B)(6), THE ORF1AB GENE WAS DETECTED AT A CT OF 20.8 AND THE N GENE WAS NOT DETECTED. THE RESULT WAS POSITIVE FOR SARS-COV-2. REPEAT RUN CASSETTE ID: (B)(6) RAN AT 4:17 PM ON (B)(6) 2021, SAMPLE ID: (B)(6), THE ORF1AB GENE WAS NOT DETECTED, THE N GENE WAS NOT DETECTED. THE RESULT WAS NEGATIVE FOR SARS-COV-2. CONSUMABLE REVIEW: NO FALSE POSITIVE RESULTS WERE REPORTED DURING AQL TESTING OF LOT AB4200A ON (B)(6) 2021. THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. THERE ARE NO ADDITIONAL OR RELATED COMPLAINTS FOR DISCREPANT RESULTS FOR LOT AB4200A REPORTED. DEVICE REVIEW: ARIES SYSTEM SN: (B)(6), MODULE SN: (B)(6). REVIEW OF THE UTILIZED DEVICE'S HISTORY WAS ACCESSED FOR A PERIOD OF 6 MONTHS PRIOR TO THE REPORTED DISCREPANT RESULT. THE CUSTOMER PREVIOUSLY REPORTED TWO FALSE POSITIVE RESULTS ON CASES (B)(4) AND (B)(6) FOR SARS-COV-2 LOT AB4019A AND LOT AB4141A WHILE USING ARIES SYSTEM M6V121131001. THERE IS NO INDICATION OF A DEVICE MALFUNCTION. SAMPLE WORK-UP: CONFIRMATION THAT THE SAMPLE WORK-UP WAS PERFORMED CONSISTENT WITH THE PACKAGE INSERT INSTRUCTIONS WAS PROVIDED BY THE CUSTOMER. CONCLUSION: THE ROOT CAUSE OF THE FALSE POSITIVE CANNOT BE DETERMINED. THERE ARE NO NCMR'S 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 FROM ORFAB TARGETS ONLY. IT WAS DETERMINED THAT WHILE A FALSE POSITIVE RESULT FROM ORFAB ONLY IS POSSIBLE, THE FREQUENCY WAS WITHIN PARAMETERS DEFINED IN ARIES SARS-COV-2 PACKAGE INSERT, 89-30000-00-865. THE RISK WAS ASSESSED ON RA-LMNX-20-0161 AND DETERMINED TO BE LOW RISK. 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 NOT MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE THE DEVICE IS SOLD OR DISTRIBUTED. HOWEVER, THE MDR IS BEING SUBMITTED TO US FDA PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL CASE DETAILS AGAINST THE CRITERIA SET FORTH IN DOCUMENT (B)(4) (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE) AND ITS APPLICABLE APPENDICES, THIS COMPLAINT DOES NOT MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE THE DEVICE IS SOLD OR DISTRIBUTED. HOWEVER, THE MDR IS BEING SUBMITTED TO US FDA PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A FALSE POSITIVE CORONAVIRUS RESULTS WITH ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD. THE NPS SWAB WAS COLLECTED AT 10-9-2021 AT 11:42 AM IN VTM. THE NPS SWAB WAS STORED IN THE REFRIGERATOR BETWEEN RUNS. ARIES RUN ONE: SAMPLE ID: (B)(6). CASSETTE SN: (B)(6). RESULT: POSITIVE FOR SARS COV-2. THE FIRST RUN WAS PERFORMED AT (B)(6) 2021 AT 2:02 PM. ARIES RUN TWO: SAMPLE ID: (B)(6). CASSETTE SN: (B)(6). RESULT: NEGATIVE FOR SARS COV-2. THE SECOND RUN WAS PERFORMED AT (B)(6) 2021 AT 4:17 PM. THE RESULTS WERE NOT REPORTED TO THE MEDICAL TEAM.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A FALSE POSITIVE CORONAVIRUS RESULTS WITH ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD. THE NPS SWAB WAS COLLECTED AT (B)(6) 2021 AT 11:42 AM IN VTM. THE NPS SWAB WAS STORED IN THE REFRIGERATOR BETWEEN RUNS. ARIES RUN ONE: SAMPLE ID - (B)(4); CASSETTE SN - (B)(4); RESULT - POSITIVE FOR SARS COV-2. THE FIRST RUN WAS PERFORMED AT (B)(6) 2021 AT 2:02 PM. .. ARIES RUN TWO: SAMPLE ID - (B)(4). CASSETTE SN - (B)(4). RESULT - NEGATIVE FOR SARS COV-2. THE SECOND RUN WAS PERFORMED AT (B)(6) 2021 AT 4:17 PM. THE RESULTS WERE NOT REPORTED TO THE MEDICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606294 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB4200A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown