BACT/ALERT FA PLUS (PLASTIC) 100 BTLS®

Description of Event or Problem

INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN UNITED STATES NOTIFIED BIOMÉRIEUX OF OBTAINING SERRATIA MARCESCENS FALSE POSITIVES WHEN USING THE BACT/ALERT FA PLUS (PLASTIC) (B)(4) BTLS - 410851 (LOT#0004103938 - EXPIRATION DATE: 14 FEB2027) IN ASSOCIATION WITH THE BCID PANEL. THE BLOOD CULTURE SAMPLE WAS COLLECTED VIA A PERIPHERAL VENOUS BLOOD DRAW FROM A PATIENT WITH UROLOGY ISSUES WHO WAS UNDERGOING TREATMENT WITH CEFPODOXIME AT THE TIME OF SAMPLING. THE BCID TEST WAS PERFORMED IMMEDIATELY AFTER THE BLOOD CULTURE BOTTLE FLAGGED POSITIVE ON THE BACT/ALERT VIRTUO SYSTEM. IT WAS REPORTED BY THE CUSTOMER THAT THE BCID TEST RESULT WAS COMMUNICATED TO THE PHYSICIAN PRIOR TO THE AVAILABILITY OF SUBCULTURE RESULTS. FOR THIS EVENT, THE FOLLOWING INFORMATION WAS PROVIDED. THE AFFECTED BOTTLE, IDENTIFIED AS (B)(6), CORRESPONDED TO PATIENT 2 AND WAS LOADED INTO THE VIRTUO INSTRUMENT ON (B)(6) 2026 AT 23:09. THE BOTTLE FLAGGED POSITIVE ON (B)(6) 2026 AT 17:09 AND WAS REMOVED FROM THE INSTRUMENT AT THE SAME TIME. THE BCID PANEL RESULTS GENERATED POSITIVE SIGNALS FOR STAPHYLOCOCCUS SPP, SERRATIA MARCESCENS. THE CUSTOMER CONFIRMED THAT THERE WAS NO GROWTH DETECTED IN EITHER THE GRAM STAIN OR SUBCULTURE FOR SERRATIA MARCESCENS FOR THE PATIENT SAMPLE. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM. THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS ACCORDINGLY. THE PRESENCE OF CONTAMINATING NUCLEIC ACID FROM NON-VIABLE MICROORGANISMS IN THE MEDIA, NOT FROM THE PATIENT SAMPLE, IS A POSSIBILITY THAT MUST BE CONSIDERED WHEN INTERPRETING THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS. THE FDA HAS REQUESTED THAT EVENTS INVOLVING NUCLEIC ACID (DNA) INTERFERENCE ASSOCIATED WITH BLOOD CULTURE BOTTLES BE SYSTEMATICALLY REPORTED WITHIN THE ADVERSE EVENT REPORTING FRAMEWORK. IN ALIGNMENT WITH FDA EXPECTATIONS AND TO ENSURE ONGOING MONITORING OF PRODUCT PERFORMANCE AND PATIENT SAFETY, BIOMÉRIEUX CONSIDERS THESE EVENTS AS REPORTABLE WITHIN THE VIGILANCE SYSTEM AND REQUIRES APPROPRIATE DOCUMENTATION, EVALUATION, AND ESCALATION WHERE NECESSARY.