BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GM EPLEX RESP PATHOGEN 2 PANEL EUA

    MDR report key: 21678798 · Received March 24, 2025

    Report

    Report Number
    3008632402-2025-00854
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 24, 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 EPLEX BASE ANALYZER SERIAL NUMBERS WERE (B)(6).. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT. NO ANALYZER MALFUNCTION WAS OBSERVED, AND THE EPLEX INSTRUMENT (SERIAL # (B)(6) WERE WORKING WITHIN DESIGN SPECIFICATIONS. THE ISSUE WAS CONSISTENT WITH A LOWER THAN INTENDED TARGET CONCENTRATION WITHIN THE SAMPLE VOLUME ANALYZED BY THE ASSAY. THIS LOT CONTAINS A RAW MATERIAL THAT HAS BEEN IDENTIFIED AS HAVING POTENTIAL FOR LEAKS. NO LEAKS WERE OBSERVED, HOWEVER SMALL AMOUNTS OF REAGENT MAY NOT BE VISIBLE. THE ISSUE IS ALSO CONSISTENT WITH A LOW TARGET CONCENTRATION WITHDRAWN AND LOADED INTO THE DELIVERY PORT.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. THESE ISSUES COULD NOT BE EXCLUDED BY THE INVESTIGATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE INFLUENZA A RESULTS WHILE USING THE GM EPLEX RESP PATHOGEN 2 PANEL EUA ASSAY ON THE EPLEX BASE ANALYZER. SAMPLE 1 INITIAL RESULT USING ANALYZER SERIAL NUMBER (B)(6) WAS H3 SUBTYPE-ONLY RESULT (INFLUENZA A MATRIX = NOT DETECTED). THE SAMPLE WAS REPEATED ON ANALYZER SERIAL NUMBER (B)(6) AND THE RESULT WAS H3 SUBTYPE-ONLY RESULT (INFLUENZA A MATRIX = NOT DETECTED). SAMPLE 2 WAS TESTED TWICE ON ANALYZER SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS H1-2009 SUBTYPE-ONLY RESULT. THE REPEAT TEST DETECTED BOTH THE INFLUENZA A MATRIX AND H1-2009 SUBTYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458837 GM EPLEX RESP PATHOGEN 2 PANEL EUA 2019-NOVEL CORONAVIRUS NUCLEIC ACID REAGENTS QJR GENMARK DIAGNOSTICS, INC. 10228315

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown