FILMARRAY TORCH MODULE

Additional Manufacturer Narrative

INVESTIGATION: (B)(6) ((B)(6) FRANCE) REPORTED A POTENTIAL FALSE-POSITIVE NEISSERIA MENINGITIDIS RESULT ON THE FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT CSF SAMPLE. A 4-MONTH-OLD INFANT PRESENTED WITH PYELONEPHRITIS ASSOCIATED WITH AN EPISODE OF MALAISE AND POOR TOLERANCE OF FEVER. ON (B)(6) 2025, AT 21:54, THE PATIENT'S CSF SAMPLE WAS COLLECTED VIA LUMBAR PUNCTURE. CEREBROSPINAL FLUID CYTOLOGY AND BIOCHEMISTRY WERE NORMAL. ON (B)(6) 2025, THE ME PANEL REPORTED A 'DETECTION' FOR N. MENINGITIDIS. ON AN UNKNOWN DATE, THE SAMPLE WAS TESTED ON AN ELITECH MENINGITIS PCR KIT WHICH RESULTED AS NEGATIVE. THE CUSTOMER REPORTED THE PATIENT WAS AFFECTED DUE TO PROLONGED IV TREATMENT (INAPPROPRIATE TREATMENT). NO PATIENT HARM WAS REPORTED. THE ANALYSIS OF THE ME PANEL RUN FILE PROVIDED BY THE CUSTOMER SHOWED UNUSUAL ACTIVITY ACROSS THE ARRAY, WITH TWO MELTS OF THE N. MENINGITIDIS ASSAY SHIFTED FROM THE CENTER OF THE TARGET MELT WINDOW. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. AN IN-HOUSE INVESTIGATION WAS PERFORMED ON THE MODULE TM08944 INSTRUMENT AND CONCLUDED VARIOUS PARTS COULD HAVE CONTRIBUTED TO THE RESULT OBSERVED IN CUSTOMER'S SITE. HOWEVER, THE INSTRUMENT COULD NOT BE DEFINITIVELY IDENTIFIED AS THE ROOT CAUSE OF THE FALSE POSITIVE. QUALITY CONTROL (QC) RECORDS FOR ME PANEL POUCH LOT# 3SUY25 (KIT LOT# 1047725) AND THE FILMARRAY TORCH INSTRUMENT (SERIAL NUMBER# (B)(6)) WERE REVIEWED. THE POUCH LOT AND INSTRUMENT PASSED QC CRITERIA. THE DISCREPANCY REPORTED BY THE CUSTOMER WAS NOT OBSERVED DURING QC TESTING. CONCLUSION: THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS A POSSIBLE INSTRUMENT ERROR OR POUCH ERROR BUT WAS UNABLE TO IDENTIFY A ROOT CAUSE. MODULE TM08944 WAS RECEIVED FOR WORK ORDER (B)(4) ON (B)(6) 2026. WHILE SERVICE WAS UNABLE TO REPLICATE THE ERROR OBSERVED AT THE CUSTOMER SITE DURING THEIR IN-HOUSE TESTING, THEY DID REPORT THAT VARIOUS PARTS WERE REPLACED, INCLUDING A MOLDED WINDOW BLADDER AND CABLES. SUBJECT MATTER EXPERTS REVIEWING THE SERVICE REPORTS OF WORK ORDER (B)(4) ALSO INDICATED THAT OPTIC-RETURN ISSUES IN THE INSTRUMENT MAY HAVE CONTRIBUTED TO THE RESULT OBSERVED IN THE RUN FILE PROVIDED; HOWEVER, A SIMILAR PHENOTYPE MAY ALSO BE SEEN FROM POUCH PLASTICS. THE INVESTIGATION FOUND THAT THE FALSE POSITIVE RESULT WAS LIKELY DUE TO EITHER AN INSTRUMENT ERROR OR POUCH MANUFACTURING ERROR BUT WAS UNABLE TO DEFINITIVELY LINK CAUSE TO EITHER POSSIBILITY. THERE ARE MULTIPLE POTENTIAL SOURCES OR CAUSES OF FALSE POSITIVE AND/OR FALSE NEGATIVE RESULTS. IT IS IMPORTANT THAT ALL ME PANEL TEST RESULTS BE INTERPRETED IN CONJUNCTION WITH OTHER CLINICAL, EPIDEMIOLOGICAL, OR LABORATORY INFORMATION. CLINICAL PERFORMANCE CAN BE FOUND IN TABLES 9, 14, AND 15 OF THE BIOFIRE ME PANEL INSTRUCTIONS FOR USE.

Description of Event or Problem

(B)(6) ((B)(6), FRANCE) REPORTED A POTENTIAL FALSE-POSITIVE NEISSERIA MENINGITIDIS RESULT ON THE FILMARRAY® MENINGITIS/ENCEPHALITIS (ME) PANEL AFTER TESTING A PATIENT CSF SAMPLE. THE CUSTOMER REPORTED THAT DUE TO THE ME PANEL THE PATIENT WAS AFFECTED DUE TO PROLONGED TREATMENT (INAPPROPRIATE TREATMENT). NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE INVESTIGATION FOUND THAT THE MOST LIKELY CAUSE OF THE DISCREPANT RESULT WAS A POSSIBLE INSTRUMENT ERROR OR POUCH ERROR.