BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL

    MDR report key: 21796864 · Received April 8, 2025

    Report

    Report Number
    3008632402-2025-01053
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 8, 2025
    Manufacturer
    GENMARK DIAGNOSTICS, INC.
    Product Code
    PAM
    PMA / PMN Number
    K181663
    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 ANALYZER SERIAL NUMBER WAS (B)(6). NO ANALYZER MALFUNCTION WAS OBSERVED AND THE EPLEX INSTRUMENT WAS FOUND TO BE WORKING WITHIN SPECIFICATIONS. PATIENT SAMPLE MATERIAL WAS SUBMITTED FOR INVESTIGATION AND TESTED WITH THE SAME LOT OF MATERIALS. DUPLICATE TESTING DETECTED ENTEROCOCCUS AND ENTEROCOCCUS FAECALIS. THE CUSTOMER¿S ALLEGATION WAS NOT REPRODUCED. THE INVESTIGATION DID NOT IDENTIFY A SPECIFIC CAUSE OF THE EVENT. 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. THIS ISSUE COULD NOT BE EXCLUDED BY THE INVESTIGATION. THE ISSUE IS ALSO CONSISTENT WITH A LOW TARGET CONCENTRATION WITHDRAWN AND LOADED INTO THE DELIVERY PORT.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.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF FALSE NEGATIVE RESULTS FOR ENTEROCOCCUS AND ENTEROCOCCUS FAECALIS WHILE USING THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A GM EPLEX BASE ANALYZER. THE EPLEX TEST SHOWED "NO TARGETS DETECTED". THE CULTURE AND MALDI RESULTS WERE ENTEROCOCCUS FAECALIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446760 EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL GRAM-POSITIVE BACTERIA AND THEIR RESISTANCE MARKERS PAM GENMARK DIAGNOSTICS, INC. 10238112

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male