BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES® SARS-COV-2 ASSAY (EUA-IVD)

    MDR report key: 17015087 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00012
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    August 21, 2020
    Report Date
    May 26, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA200127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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) FORM 483 ISSUED ON (B)(6) 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) FORM 483 ISSUED ON (B)(6) 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. THE CUSTOMER SITE REPORTED THAT OUT OF 80 (POSITIVE AND NEGATIVE) SAMPLES TESTED, 20 OF THE POSITIVE SAMPLES (CT >30) WERE DETECTED AS (FALSE) NEGATIVE BY THE ARIES. THE COMPARATIVE ASSAY USED WAS COBAS, AND DISCORDANT RESULTS WERE FURTHER CONFIRMED USING THE ALTONA SARS-COV-2 KITS. DATA REVIEW: CUSTOMER IDENTIFIED THAT THE SAMPLES TESTED WERE PART OF COVID TESTING VALIDATION IN DETERMINING IF THE ARIES ASSAY WOULD SUIT THEIR NEEDS. THE ALLEGED FALSE RESULTS FROM THE SAMPLES TESTED ON THE ARIES SYSTEM WERE NOT REPORTED OUT. CUSTOMER DID NOT PROVIDE RUN DATA OR RESULT REPORTS. FURTHER DATA REVIEW COULD BE COMPLETED. CONSUMABLE REVIEW: ARIES LOT: AB0691A. THERE ARE NO NCMRS ASSOCIATED WITH ARIES LOT NUMBER AB0691A. NO INVALIDS OR FALSE RESULTS WERE NOTED IN ARIES QC OF LOT AB0691A. THERE ARE NO INDICATIONS OF A CONSUMABLE MALFUNCTION. THE CUSTOMER DID NOT PROVIDE TECHNICAL SUPPORT WITH DATA OR DEVICE INFORMATION. WITHOUT THIS INFORMATION FQA CANNOT COMPLETE THE DATA REVIEW, DEVICE REVIEW, OR SITE PERFORMANCE PORTIONS OF THE TECHNICAL INVESTIGATION. DEVICE REVIEW: DEVICE UTILIZED WAS NOT CAPTURED IN COMPLAINT CASE. CUSTOMER THAT REPORTED THE EVENT ONLY HAS ONE ARIES SYSTEM INSTALLED, 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. CONCLUSION: THE CAUSE OF THE REPORTED FALSE NEGATIVE SARS RESULTS CANNOT BE DETERMINED AS THE CUSTOMER DID NOT PROVIDE TECHNICAL SUPPORT WITH FURTHER INFORMATION FOR INVESTIGATION. THIS CASE WAS PREVIOUSLY ASSESSED BY TECHNICAL SUPPORT AND NO PRE OR MDR WAS TRIGGERED BY THEIR ANSWERS OF THE RISK ASSESSMENT QUESTIONS. DURING A RETROSPECTIVE REVIEW OF LUMINEX CORPORATION COMPLAINT DATA, AS COMMITTED TO US FDA DURING THE CONTAINMENT OF OBSERVATION #3; FEI NUMBER: (B)(4) FORM 483 ISSUED ON (B)(6) 2023. THIS POTENTIAL ADVERSE EVENT WAS IDENTIFIED ON (B)(6) 2023 DURING A REVIEW COMPLETED BY TECHNICAL SUPPORT, PMS, AND FQA. THIS COMPLAINT OF A FALSE RESULT 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
    1915477 ARIES® SARS-COV-2 ASSAY (EUA-IVD) ARIES® SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB0691A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown