VIRTUO, A UNIT - 411660

Description of Event or Problem

INTENDED USE: BACT/ALERT® VIRTUO¿ MICROBIAL DETECTION SYSTEM IS AN AUTOMATED MICROBIAL TEST SYSTEM CAPABLE OF INCUBATING, AGITATING, AND CONTINUOUSLY MONITORING FOR THE DETECTION OF AEROBIC, FACULTATIVE, AND ANAEROBIC MICROORGANISM GROWTH FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: ON (B)(6) 2026, A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX THAT ONE OF THEIR OPERATORS WAS INJURED WHEN THE WASTE TRAY DOOR OF THEIR VIRTUO, A UNIT (REF 411660, SERIAL (B)(6)) FELL ON THE OPERATOR'S FOOT. THE CUSTOMER REPORTED THAT THE OPERATOR WAS TRYING TO EMPTY THE VIRUTO'S WASTE TRY AND THE WASTE TRAY DOOR FELL ONTO THE OPERATOR'S FOOT. THE INJURED EMPLOYEE WAS SENT TO URGENT CARE, WAS PUT ON LEAVE FOR THE REST OF THE WEEK, AND THEN RETURNED TO WORK ON MODIFIED DUTY. BIOMÉRIEUX HAS REQUESTED DETAILS REGARDING THE SPECIFIC INJURY AND TREATMENT NECESSARY, BUT THE CUSTOMER DECLINED TO PROVIDE FURTHER INFORMATION. THE INJURY OCCURRED ON (B)(6) 2026 BUT WAS NOT REPORTED TO BIOMÉRIEUX UNTIL (B)(6) 2026. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE ON (B)(6) 2026 TO REPAIR THE VIRTUO. UPON ARRIVAL, THE FSE IDENTIFIED THAT THE DRAWER WAS MISSING HARDWARE TO STOP THE DRAWER WHEN OPENING IT, THE HARDWARE WAS NOWHERE TO BE FOUND. THE MISSING HARDWARE WAS REPLACED AND THE WASTE BIN WAS TESTED TO ENSURE THE DRAWER STOPPED AS INTENDED. THE FSE SHOWED THE CUSTOMER THE PARTS THAT WERE INSTALLED. IT WAS ALSO NOTED THAT THE FSE ADDRESSED CONCERNS WITH THE CUSTOMER THAT THEY HAVE WITNESSED TECHNICIANS SLAMMING THE INSTRUMENT DOORS IN THE PAST. LOCAL CUSTOMER SERVICE (LCS) CONFIRMED THAT THE INSTRUMENT WAS INSTALLED AT THE CUSTOMER'S SITE ON 23-DEC-2020. THERE HAVE BEEN NO OTHER RECORDED ISSUES FOR THIS INSTRUMENT RELATED TO WASTE DOOR ISSUES SINCE INSTALLATION. THIS INCIDENT IS CONSIDERED TO BE A MALFUNCTION OF THE VIRTUO A UNIT AS THE WASTE TRAY DOOR SHOULD NOT BECOME DETACHED FROM THE INSTRUMENT DURING USE. THIS DISCREPANCY WAS REVIEWED FOR VIGILANCE REPORTING ACCORDING TO 21 CFR 803 CONCERNING MEDICAL DEVICE REPORTING. THIS INCIDENT IS CONSIDERED TO BE A MALFUNCTION OF THE VIRTUO A UNIT AS THE WASTE TRAY DOOR SHOULD NOT BECOME DETACHED FROM THE INSTRUMENT DURING USE. ALTHOUGH IT IS UNKNOWN IF THE OPERATOR SUSTAINED AN INJURY THAT MEETS THE DEFINITION OF A SERIOUS INJURY, BIOMÉRIEUX CONSIDERS THAT THE PRODUCT MALFUNCTIONED IN A WAY THAT MIGHT LEAD TO SERIOUS INJURY OR SERIOUS DETERIORATION IN THE STATE OF HEALTH IF IT WERE TO RECUR. BIOMÉRIEUX HAS DETERMINED THIS EVENT TO BE REPORTABLE TO FDA AS A MALFUNCTION EVENT.