BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20687983 · Received November 14, 2024

    Report

    Report Number
    3008632402-2024-03311
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    August 25, 2024
    Report Date
    November 28, 2024
    Manufacturer
    GENMARK DIAGNOSTICS, INC.
    Product Code
    PAM
    UDI-DI
    00857167005320
    PMA / PMN Number
    K181663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO RUN MALFUNCTION WAS OBSERVED AND THE INSTRUMENT WAS WORKING WITHIN DESIGN SPECIFICATIONS. INTERNAL CONTROL RESULTS WERE VALID AND SUCCESSFUL. AN INTERNAL REVIEW OF QC RELEASE DATA FOR THE AFFECTED LOT NUMBER CONFIRMED THE LOT SUCCESSFULLY MET THE ESTABLISHED QC RELEASE SPECIFICATIONS. A REVIEW OF THE PROVIDED DATA INDICATED THAT THE ALLEGED SAMPLE IS AT THE LIMIT OF DETECTION. THE TARGET CONCENTRATION WAS LIKELY AT OR NEAR THE ANALYTICAL SENSITIVITY OF THE ASSAY, RESULTING IN NO TARGET DETECTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE GM EPLEX BASE UNIT IS (B)(6). A REVIEW OF THE RAW DATA FOR THE RUN SHOWED ROBUST INTERNAL CONTROLS. THE GENERATED SIGNAL WAS BELOW THE THRESHOLD FOR THE ENTEROCOCCUS FAECALIS TARGET AND NO SIGNAL WAS GENERATED FOR THE ENTEROCOCCUS TARGET. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED A FALSE NEGATIVE ENTEROCOCCUS FAECALIS RESULT FOR ONE PATIENT SAMPLE TESTED WITH THE EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL ON A GM EPLEX BASE UNIT. THE ASSAY DID NOT DETECT ANY TARGETS. THE ORIGINAL GRAM STAIN OF THE SAMPLE SHOWED GRAM-POSITIVE COCCI RESEMBLING STREPTOCOCCUS. THE BLOOD AGAR PLATE OF THE SAMPLE HAD GAMMA STREPTOCOCCUS-LIKE COLONIES CONSISTENT WITH ENTEROCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196700 EPLEX BLOOD CULTURE IDENTIFICATION PANEL - GRAM POSITIVE (BCID-GP) PANEL GRAM-POSITIVE BACTERIA AND THEIR RESISTANCE MARKERS PAM GENMARK DIAGNOSTICS, INC. 10212863 00857167005320

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female