BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 12707947 · Received October 27, 2021

    Report

    Report Number
    1650733-2021-00018
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    October 13, 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 (B)(6) 2021, THE CUSTOMER CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT A DISCREPANT FALSE POSITIVE RESULT FOR ARIES SARS-COV2-EUA ASSAY PN: 50-10047 LOT: AB4141. PROVIDED RUN FILES SHOW INITIAL RUN AS A POSITIVE, WHILE 3RD PARTY HOLOGIC PANTHER COVID ASSAY YIELDED TRIPLICATE NEGATIVE RESULTS. CONFIRMATION TESTING WAS NOT PERFORMED USING THE ARIES ASSAY. CASSETTE ID: (B)(4) RAN AT 12:32 PM ON (B)(6) 2021, SAMPLE ID: (B)(4), THE ORF1AB GENE WAS DETECTED AT A CT OF 26.1 AND THE N GENE WAS NOT DETECTED. RESULT WAS SARS-COV-2 POSITIVE. RESULT WAS NOT REPORTED TO PHYSICIAN. CONFIRMATION TESTING USING HOLOGIC PANTHER RESULTS PERFORMED IN TRIPLICATE WERE NOT PROVIDED TO LUMINEX BUT WERE REPORTED TO PHYSICIAN. RESULTS WERE SARS-COV-2 NEGATIVE. CONSUMABLE REVIEW: NO FALSE POSITIVE RESULTS WERE REPORTED DURING AQL TESTING OF LOT: AB4141A ON 09/13/2021. THERE ARE NO NCMRS ASSOCIATED WITH THIS LOT. THERE ARE NO ADDITIONAL OR RELATED COMPLAINTS FOR DISCREPANT RESULTS FOR LOT: AB4141A 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 SAME CUSTOMER PREVIOUSLY REPORTED FALSE POSITIVE RESULTS ON CASES (B)(4) FOR SARS-COV-2 LOTS: AB2010A, AB2141A, AND AB4079A WHILE USING ARIES SYSTEM (B)(6). 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

    THE CUSTOMER REPORTED A FALSE POSITIVE CORONAVIRUS RESULTS WITH ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD. THE NPS SWAB WAS COLLECTED IN VTM. THE SAMPLE WAS COLLECTED AT 11:09 AM ON (B)(6) 2021 AND ANALYZED ON THE ARIES SYSTEM AT 12:32 PM ON THE SAME DAY. ARIES RUN: SAMPLE ID: (B)(4). CASSETTE SN: (B)(6). RESULT: POSITIVE FOR SARS COV-2, ORF1AB WAS DETECTED AT 26.1 CT. HOLOGIC PANTHER: RESULT: NEGATIVE (IN TRIPLICATE) FOR SARS COV-2. THE RESULTS FROM THE ARIES TEST WERE NOT REPORTED TO THE PHYSICIAN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE POSITIVE CORONAVIRUS RESULTS WITH ARIES SARS-COV-2 ASSAY (24 CASSETTES) - IVD. THE NPS SWAB WAS COLLECTED IN VTM. THE SAMPLE WAS COLLECTED AT 11:09 AM ON 10-13-2021 AND ANALYZED ON THE ARIES SYSTEM AT 12:32 PM ON THE SAME DAY. ARIES RUN: - SAMPLE ID (B)(4). - CASSETTE SN (B)(4). - RESULT: POSITIVE FOR SARS COV-2, ORF1AB WAS DETECTED AT 26.1 CT. HOLOGIC PANTHER: - RESULT: NEGATIVE (IN TRIPLICATE) FOR SARS COV-2. THE RESULTS FROM THE ARIES TEST WERE NOT REPORTED TO THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606297 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB4141A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown