BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARIES FLU A/B & RSV ASSAY

    MDR report key: 11181405 · Received January 15, 2021

    Report

    Report Number
    1650733-2021-00001
    Event Type
    Death
    Date Received
    January 15, 2021
    Date of Event
    December 22, 2020
    Report Date
    January 15, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    OCC
    UDI-DI
    00840487100158
    PMA / PMN Number
    K161220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP #001 FOR 1650733-2021-00001 IS TO CORRECT THE DATE OF EVENT (SECTION B3) TO ON (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    BASED ON THE INVESTIGATION COMPLETED AT THIS TIME, THERE IS NO INDICATION OF DEVICE MALFUNCTION. THE EVENT IS ALSO BEING INVESTIGATED SEPARATELY UNDER ESCALATION CASE (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A DISCREPANCY RESULTS FOR INFLUENZA B ON ARIES FLU A/B AND RSV ASSAY. ARIES: INFLUENZA B POSITIVE. SAMPLE WAS NOT REPEATED ON ARIES. CONFIRMATION TESTING, (B)(6) PUBLIC HEALTH LAB PCR STATE (MULTIPLEX RT PCR): INFLUENZA B NEGATIVE. THE PATIENT WAS ADMITTED DUE TO FEVER, CHILLS, SOB, WEAKNESS, HYPOTENSION, PNEUMONIA, SEPSIS. THE ARIES FLU B RESULT WAS RELEASED TO THE PHYSICIAN ON (B)(6) 2020 @ 1959. THE PATIENT WAS RECEIVING FOLLOWING THE TREATMENTS PRIOR TO ARIES RESULT, AZITHROMYCIN, VANCOMYCIN, ZOSYN; THE ADDITION OF TAMIFLU WAS ADDED AFTER THE ARIES RESULT WAS RELEASED. THE SAMPLE WAS NOT STORED BEFORE TESTING ON THE ARIES. THIS PATIENT'S SAMPLE CAME TO THE LABORATORY FROM THE EMERGENCY DEPARTMENT AND WAS TESTED IMMEDIATELY ON DEMAND (IT WAS ORDERED STAT). ON (B)(6) 2020, SAMPLE RAN ON ARIES (B)(4) MODULE A POSITION A4 RUN: ARIESK1-RUN#493-A SAMPLE ID (B)(6) RESULT: INFLUENZA A NEGATIVE, RSV NEGATIVE, INFLUENZA B POSITIVE (CT= 39.4 TM= 78.6). THE SAMPLE WAS STORED REFRIGERATED PRIOR TO TESTING AT (B)(6) PUBLIC HEALTH LAB AND RESULTED AS A FLU B NEGATIVE. QC WAS RAN ON THE ARIES INSTRUMENT 9 HOURS PRIOR ON A4 AND WAS SUCCESSFUL. DATE/TIME OF EXPIRY: (B)(6) 2020 @ 0554, CAUSE OF PATIENT DEATH: KLEBSIELLA PNEUMONIAE SEVERE SEPSIS SECONDARY TO BILATERAL PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72190 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