BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FILMARRAY PNEUMO PANEL

    MDR report key: 25175369 · Received May 14, 2026

    Report

    Report Number
    3002773840-2026-00010
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BIOFIRE DIAGNOSTICS, LLC
    Product Code
    QDP
    UDI-DI
    00815381020178
    PMA / PMN Number
    K243222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) REPORTED A POTENTIAL FALSE POSITIVE CTX-M RESULT ON THE BIOFIRE FILMARRAY PNEUMONIA PANEL (PN PANEL) AFTER TESTING A PATIENT'S SPUTUM SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE PN PANEL RESULT, THE PATIENT POTENTIALLY RECEIVED INAPPROPRIATE TREATMENT MODIFICATION; HOWEVER, NO SUBSEQUENT PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. BIOFIRE IS CURRENTLY INVESTIGATING THIS EVENT. PRELIMINARY INVESTIGATION INDICATES A MALFUNCTION ASSOCIATED WITH A HIGH TM CTX-M SIGNATURE, SIMILARLY OBSERVED WITH THE CTX-M ASSAY HGDNA CROSS-REACTIVITY. A PREVENTIVE ACTION WAS IMPLEMENTED IN THE FSCA 5790 UPDATE SOFTWARE RELEASE TO MITIGATE THE POTENTIAL FOR OCCURRENCE OF CTX-M FALSE POSITIVE RESULTS ASSOCIATED WITH HUMAN GENOMIC DNA (HGDNA) CROSS-REACTIVITY IN THE FIELD. THIS SOFTWARE UPDATE WAS RELEASED IN (B)(6) 2025. AT THE TIME THIS COMPLAINT WAS RECEIVED, THE CUSTOMER HAD NOT IMPLEMENTED THE UPDATED SOFTWARE. THE CUSTOMER HAS SINCE BEEN ADVISED TO PERFORM THE SOFTWARE UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547628 FILMARRAY PNEUMO PANEL FILMARRAY PNEUMO PANEL QDP BIOFIRE DIAGNOSTICS, LLC RFIT-ASY-0144 2164125 00815381020178

    Patients

    Seq Age Sex Outcome Treatment
    1