BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARIES FLU A/B & RSV ASSAY

    MDR report key: 11231005 · Received January 26, 2021

    Report

    Report Number
    1650733-2021-00002
    Event Type
    Death
    Date Received
    January 26, 2021
    Date of Event
    January 8, 2021
    Report Date
    January 26, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    OCC
    UDI-DI
    00840487100158
    PMA / PMN Number
    K161220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF DEATH WAS CONFIRMED AS CARDIOPULMONARY ARREST SECONDARY TO COVID-19 PNEUMONIA AND INFLUENZA B. THE RESULT OF THE ARIES® FLU A/B & RSV ASSAY WAS INFLUENZA B. BASED THE FACT THAT THE ARIES RESULT WAS INFLUENZA B AND THE PATIENT DIED FROM INFLUENZA B, THERE IS NO INDICATION OF A FALSE POSITIVE RESULT AND THEREFORE NO PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED INFLUENZA B POSITIVE ON ARIES FLU A/B AND RSV ASSAY. ARIES: INFLUENZA B POSITIVE SAMPLE WAS NOT REPEATED ON ANOTHER PLATFORM, THERE IS NO DISCREPANCY TO REPORT. ON 1/22/2021 LUMINEX WAS MADE AWARE THAT THERE WAS A PATIENT DEATH INVOLVED THE PATIENT TESTED POSITIVE FOR BOTH COVID AND FLU B, THE FLU B WAS RESULTED FROM THE ARIES ASSAY. THE PATIENT WAS ADMITTED DUE TO FATIGUE, SOB, COUGH, CHILLS, NAUSEA, HYPOXIA. THE ARIES FLU B RESULT WAS RELEASED TO THE PHYSICIAN ON (B)(6) 2021 @ 2055. THE PATIENT ALSO TESTED POSITIVE FOR COVID OFF-SITE A WEEK PRIOR (APPROX. (B)(6) 2020). CUSTOMER DID NOT KNOW WHICH PLATFORM WAS USED FOR COVID TESTING OR WHICH GENES WERE DETECTED. THE PATIENT WAS RECEIVING FOLLOWING THE TREATMENTS PRIOR TO ARIES RESULT, CEFTRIAXONE AND DOXYCYCLINE ((B)(6) 2021), REMDESIVIR ((B)(6) 2021), AZITHROMYCIN; THE ADDITION OF TAMIFLU WAS ADDED ((B)(6) 2021) AFTER THE ARIES RESULT WAS RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128864 ARIES FLU A/B & RSV ASSAY ARIES® FLU A/B & RSV ASSAY OCC LUMINEX CORPORATION 50-10020 AB1226A 00840487100158

    Patients

    Seq Age Sex Outcome Treatment
    1 Death