BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL

    MDR report key: 21833124 · Received April 14, 2025

    Report

    Report Number
    3008632402-2025-01122
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 18, 2025
    Report Date
    May 2, 2025
    Manufacturer
    GENMARK DIAGNOSTICS, INC.
    Product Code
    PEN
    PMA / PMN Number
    K182619
    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 GM EPLEX BASE UNIT SERIAL NUMBER WAS (B)(6). NO MALFUNCTION WAS FOUND FOR THE EPLEX INSTRUMENT, AND IT WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. ANTIMICROBIAL RESISTANCE CAN OCCUR VIA MULTIPLE MECHANISMS, AND THE BCID-GN PANEL IS DESIGNED TO DIRECTLY DETECT THE NUCLEIC ACID OF A RESISTANCE GENE. A 'NOT DETECTED' RESULT FOR AN ANTIMICROBIAL RESISTANCE GENE SHOULD NOT BE INTERPRETED AS ANTIMICROBIAL SUSCEPTIBILITY TO A SPECIFIC ORGANISM. IN ADDITION, ESBL RESISTANCE CAN BE DUE TO MECHANISMS OTHER THAN THE ACQUISITION OF THE CTX-M RESISTANCE GENE. A 'NOT DETECTED' FOR THE SPECIFIC CTX-M RESISTANCE GENE PRESENT IN THE E. COLI MAY BE DUE TO SEQUENCE VARIATION AND/OR ASSAY LIMITATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF FALSE NEGATIVE CTX-M RESULT WHILE USING THE EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL ON A GM EPLEX BASE UNIT. THE RESULT FROM THE EPLEX WAS NO DETECTION FOR ANY OF THE RESISTANCE GENES AND DETECTED FOR E. COLI. THE CULTURE RESULT WAS E. COLI. EXTENDED-SPECTRUM BETA-LACTAMASES (ESBL) WAS CONFIRMED USING PHOENIX ESBL TEST. REFER TO THE ATTACHMENT TO MEDWATCH FOR THE SUSCEPTIBILITY TESTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080542 EPLEX BLOOD CULTURE IDENTIFICATION GRAM NEGATIVE (BCID-GN) PANEL GRAM-NEGATIVE BACTERIA AND ASSOCIATED RESISTANCE MARKERS PEN GENMARK DIAGNOSTICS, INC. 10230394

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female