FILMARRAY PNEUMO PANEL

Description of Event or Problem

(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.