BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GM EPLEX RESP PATHOGEN 2 PANEL EUA

    MDR report key: 22017824 · Received May 14, 2025

    Report

    Report Number
    3008632402-2025-01483
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 21, 2025
    Report Date
    May 14, 2025
    Manufacturer
    GENMARK DIAGNOSTICS, INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA201822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT'S SERIAL NUMBER IS (B)(6). THE ISSUE IS CONSISTENT WITH LOW VIRUS TITERS THAT CAN RESULT IN THE DETECTION OF THE INFLUENZA A SUBTYPE WITHOUT THE INFLUENZA A MATRIX. DETECTION OF THE INFLUENZA A SUBTYPE WITHOUT THE INFLUENZA A MATRIX CAN ALSO INDICATE THE PRESENCE OF A NOVEL STRAIN NOT FULLY TARGETED BY THE ASSAY. THE ISSUE IS ALSO CONSISTENT WITH A LOW TARGET CONCENTRATION WITHDRAWN AND LOADED INTO THE DELIVERY PORT. THIS CAN CREATE LIMIT OF DETECTION CHALLENGES IF THE CONCENTRATION IS AT OR NEAR THE ANALYTICAL SENSITIVITY OF THE ASSAY. ADDITIONALLY, THIS LOT CONTAINS A RAW MATERIAL WITH EVEN SMALL, UNOBSERVABLE LEAKS, WHICH COULD RESULT IN LOWER THAN INTENDED REAGENT CONCENTRATIONS, POTENTIALLY AFFECTING THE ASSAY'S PERFORMANCE AND LEADING TO INACCURATE RESULTS. THIS ISSUE COULD NOT BE EXCLUDED BY THE INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS USING THE GM EPLEX RESP PATHOGEN 2 PANEL EUA FOR 1 PATIENT SAMPLE ON AN EPLEX SYSTEM. IT WAS REPORTED THAT INFLUENZA A H1-2009 SUBTYPE WAS DETECTED, BUT THERE WAS NO SIGNAL FOUND FOR THE INFLUENZA A TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880862 GM EPLEX RESP PATHOGEN 2 PANEL EUA 2019-NOVEL CORONAVIRUS NUCLEIC ACID REAGENTS QJR GENMARK DIAGNOSTICS, INC. 10235330

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown