BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES® SARS-COV-2 ASSAY (EUA-IVD)

    MDR report key: 17015067 · Received May 26, 2023

    Report

    Report Number
    1650733-2023-00006
    Event Type
    Malfunction
    Date Received
    May 26, 2023
    Date of Event
    April 30, 2021
    Report Date
    May 26, 2023
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    PMA / PMN Number
    EUA200127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (B)(6) 2021 CUSTOMER (B)(6) MEDICAL CENTER CONTACTED LUMINEX TECHNICAL SUPPORT TO REPORT FALSE NEGATIVE RESULTS FOR ARIES SARS-COV-2 EUA ASSAY PN:50-10047 HAD OCCURRED DURING CUSTOMER QC TESTING BY MEANS OF LOT TO LOT COMPARISON USING A PATIENT SAMPLE. CUSTOMER DID NOT PROVIDE THE LOT NUMBER, SUF, OR ASSAY RUN DATA FILES. CONSUMABLE REVIEW: LOT INFORMATION WAS NOT PROVIDED ON THIS COMPLAINT CASE. 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. SAMPLE WORK-UP: CONFIRMATION THAT THE SAMPLE WORK-UP WAS PERFORMED CONSISTENT WITH THE PACKAGE INSERT INSTRUCTION WAS PROVIDED BY THE CUSTOMER. CUSTOMER DID NOT PROVIDE SAMPLE STORAGE OR AGE OF SAMPLE INFORMATION. CONCLUSION: THE ROOT CAUSE OF THE FALSE NEGATIVE RESULTS CANNOT BE DETERMINED. THERE IS NO INDICATION OF A HARDWARE MALFUNCTION. MAS REVIEW OF CUSTOMER DATA AT CUSTOMER SITE ALLOWED THE MAS TO CONCLUDE THE POTENTIAL CAUSE OF THE FALSE NEGATIVE RESULT WAS THAT THE PATIENT SAMPLE BEING USED FOR QC TESTING WAS LIKELY NEAR THE LIMIT OF DETECTION FOR THE ARIES SARS-COV-2 ASSAY. BORDERLINE LOD SAMPLE CONCENTRATION WOULD ACCOUNT FOR THE VARIATION IN SAMPLE RESULTS. THIS CASE WAS NOT ORIGINALLY IDENTIFIED AS MEETING THE REQUIREMENTS FOR MDR REPORTING. THIS COMPLAINT OF A FALSE RESULT ON THE EUA ARIES SARS-COV-2 ASSAY 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
    1670538 ARIES® SARS-COV-2 ASSAY (EUA-IVD) ARIES® SARS-COV-2 ASSAY QJR LUMINEX CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown