FILMARRAY TORCH MODULE

Additional Manufacturer Narrative

INVESTIGATION: (B)(6) HOSPITAL [(B)(6), UNITED STATES] REPORTED A POTENTIAL FALSE POSITIVE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX RESULT ON THE FILMARRAY TORCH MODULE WITH THE BIOFIRE BCID2 PANEL AFTER TESTING A POSITIVE BLOOD CULTURE SAMPLE FROM A 78-YEAR-OLD FEMALE PATIENT PRESENTING WITH CELLULITIS ACCOMPANIED BY FEVER, ALTERED MENTAL STATUS (AMS), AND BACTEREMIA. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. ON (B)(6) 2026, A POSITIVE BLOOD CULTURE SAMPLE WAS TESTED ON TORCH MODULE (B)(6) WITH THE BCID2 PANEL AND REPORTED A. CALCOACETICUS-BAUMANNII COMPLEX AS DETECTED; ALSO REPORTED ENTEROBACTERALES AND E. COLI AS DETECTED. ON AN UNKNOWN DATE, THE GRAM STAIN FROM THE AEROBIC BOTTLE SHOWED GRAM-NEGATIVE RODS (GNR). ON AN UNKNOWN DATE, THE AEROBIC BOTTLE CULTURE GREW ESCHERICHIA COLI. ON (B)(6) 2026, THE SAMPLE WAS TESTED ON A DIFFERENT TORCH MODULE WITH THE BCID2 PANEL AND REPORTED A. CALCOACETICUS-BAUMANNII COMPLEX AS NOT DETECTED; REPORTED ENTEROBACTERALES AND E. COLI AS DETECTED. THE A. CALCOACETICUS-BAUMANNII COMPLEX DETECTION WITH THE BCID2 PANEL RESULT ON TORCH MODULE (B)(6) IMPACTED PATIENT MANAGEMENT; THE PATIENT¿S ANTIBIOTIC THERAPY WAS BROADENED. NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. ANALYSIS OF THE INITIAL BCID2 PANEL RUN FILE PROVIDED BY THE CUSTOMER SUGGESTED A POTENTIAL ISSUE WITH TORCH MODULE (B)(6). ON (B)(6) 2026, TORCH MODULE (B)(6) WAS RETURNED TO BIOFIRE FOR SERVICE FOR AN IN-HOUSE INVESTIGATION. THE MANIFOLD, PLUNGERS, AND BEAD BEATER BAR WERE CHECKED, AND NO ISSUES WERE IDENTIFIED. PREVENTATIVE MAINTENANCE WAS PERFORMED, AND THE INSTRUMENT PASSED ALL OUTGOING TESTING. THE FALSE POSITIVE RESULT OBSERVED AT THE CUSTOMER SITE WAS NOT REPRODUCED IN SERVICE. QC RECORDS FOR LOT 2466425 AND INSTRUMENT (B)(6) WERE REVIEWED. ALL QC METRICS FOR THE POUCH LOT AND INSTRUMENT WERE MET, AND THEY PASSED QC. CONCLUSION: THE ROOT CAUSE OF THE POTENTIAL FALSE POSITIVE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX RESULT COULD NOT BE DEFINITIVELY DETERMINED. HOWEVER, THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE WAS DUE TO AN INSTRUMENT ERROR. ANALYSIS OF THE INITIAL BCID2 PANEL RUN FILE REVEALED AN INCREASE IN BASELINE AMPLIFICATION AND BACKGROUND NOISE, WHICH WAS INTERPRETED AS MELTING CURVES ACROSS ALL ASSAYS. THIS BACKGROUND NOISE LED TO A FALSE POSITIVE DETECTION FOR THE ACB COMPLEX, AS IT FELL WITHIN THE ASSAY¿S MELTING TEMPERATURE WINDOW. ADDITIONAL RUN FILES FROM INSTRUMENT (B)(6) ALSO DEMONSTRATED ELEVATED BASELINE AMPLIFICATION. THE INSTRUMENT WAS SUBSEQUENTLY BROUGHT IN FOR SERVICE; HOWEVER, THE FALSE POSITIVE RESULT COULD NOT BE REPRODUCED DURING EVALUATION. PREVENTATIVE MAINTENANCE WAS PERFORMED, AND ALL POST-SERVICE TESTING PASSED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED, THE MOST LIKELY EXPLANATION IS AN INTERMITTENT INSTRUMENT-RELATED ISSUE THAT LEAD TO THE FALSE POSITIVE RESULT. ALL BIOFIRE BCID2 PANEL RESULTS ARE INTENDED TO BE INTERPRETED IN CONJUNCTION WITH GRAM STAIN RESULTS. IN SOME CASES, THE GRAM STAIN RESULT AND THE BIOFIRE BCID2 PANEL RESULT MAY BE DISCREPANT. IN THESE CASES, THE BIOFIRE BCID2 PANEL RESULTS SHOULD BE CONFIRMED, E.G., BY CULTURE OR OTHER LABORATORY, EPIDEMIOLOGICAL, OR CLINICAL FINDINGS. CLINICAL PERFORMANCE CAN BE FOUND IN THE BIOFIRE BCID2 PANEL INSTRUCTIONS FOR USE: HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/US/ALL?KEYCODE=ITI0048 FILMARRAY TORCH OPERATORS MANUAL: HTTPS://WWW.BIOFIREDX.QARAD.EIFU.ONLINE/ITI/US/ALL?KEYCODE=ITI0066.

Description of Event or Problem

SUMMARY: THE CUSTOMER [MASSACHUSETTS, UNITED STATES] REPORTED A POTENTIAL FALSE POSITIVE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX RESULT ON THE FILMARRAY TORCH MODULE AFTER TESTING A POSITIVE PATIENT BLOOD CULTURE SAMPLE WITH THE BIOFIRE BCID2 PANEL. THE CUSTOMER REPORTED THAT DUE TO THE FILMARRAY TORCH MODULE RESULT WITH THE BIOFIRE BCID2 PANEL, THE PATIENT EXPERIENCED INDIRECT HARM, SPECIFICALLY INAPPROPRIATE TREATMENT, WHICH MIGHT LEAD TO SERIOUS INJURY IF IT WERE TO RECUR. NO PATIENT HARM WAS REPORTED. A POTENTIAL PRODUCT MALFUNCTION WAS IDENTIFIED. THE ROOT CAUSE OF THE POTENTIAL FALSE POSITIVE ACINETOBACTER CALCOACETICUS-BAUMANNII COMPLEX RESULT COULD NOT BE DEFINITIVELY DETERMINED. HOWEVER, THE INVESTIGATION CONCLUDED THE MOST LIKELY CAUSE WAS DUE TO AN INSTRUMENT ERROR.