BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GM EPLEX RESP PATHOGEN 2 PANEL EUA

    MDR report key: 21688298 · Received March 25, 2025

    Report

    Report Number
    3008632402-2025-00867
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 25, 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 INSTRUMENTS (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 THE ISSUE IS ALSO CONSISTENT WITH A LOW TARGET CONCENTRATION WITHDRAWN AND LOADED INTO THE DELIVERY PORT.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 RESULTS USING THE GM EPLEX RESP PATHOGEN 2 PANEL EUA FOR 2 PATIENT SAMPLES ON AN EPLEX SYSTEM. SAMPLE A WAS TESTED 2 TIMES. SAMPLE A WAS TESTED USING ANALYZER SERIAL NUMBER (B)(6). IT WAS REPORTED THAT INFLUENZA A H3 SUBTYPE WAS DETECTED FOR BOTH TESTS, AND THERE WAS NO SIGNAL FOUND FOR THE INFLUENZA A TARGET. SAMPLE B: ON 21-FEB-2025, IT WAS REPORTED THAT THE INFLUENZA A H1-2009 SUBTYPE- ONLY WAS DETECTED USING ANALYZER SERIAL NUMBER (B)(6). THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT (ANALYZER SERIAL NUMBER (B)(6) AND BOTH THE INFLUENZA A MATRIX AND H1-2009 SUBTYPE WERE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133106 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