BACT/ALERT® VIRTUO® 411660Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 03573026369767), received between Dec 13, 2017 and May 21, 2026 — classified as 2 injuries, 35 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (6 reports).

1 FDA recall record name this device's identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 27, 2018Terminated

   The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows relocation of the four (4) resident calibration standards so that Field System Engineers (FSE) can service the associated cells P24 - P27, where the calibration standards typically reside. If the calibration standards are not returned to the designated locations, an anomaly may occur.

   Z-0228-2019 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Difficult to Open or Close

  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 HARD

  Patient problems: Insufficient Information

  MAUDE report 25240729 ↗
• MalfunctionMar 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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 AND FROM BLOOD PLATELET SAMPLES. IN BLOOD BANK FACILITIES, THE BACT/ALERT® VIRTUO® MICROBIAL DETECTION SYSTEM WILL PROVIDE IN-PROCESS TESTING FOR THE PRESENCE OR ABSENCE OF MICROORGANISMS. DESCRIPTION OF THE ISSUE A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING A DELAYED RESULT WHEN USING THE VIRTUO, A UNIT - REFERENCE 411660 (SERIAL NUMBER (B)(6). THE CUSTOMER NOTIFIED THAT HE HAS TWO VIRTUO INSTRUMENTS : A VIRTUO AT LUTON AND A VIRTUO AT BEDFORD. IT IS UNDERSTOOD THAT POSITIVE BOTTLE RESULTS FROM LUTON HAVE NOT BEEN RECEIVED TO THE LABORATORY INFORMATION SYSTEM (LIS) AT BEDFORD WHERE THE BOTTLES ARE FURTHER TESTED. THE CUSTOMER INDICATED THAT THE GRAM STAINING HAS NOT BEEN PERFORMED FOR THESE BOTTLES BECAUSE BEDFORD SITE HAS NOT RECEIVED THESE BOTTLES. THEREFORE, FOR NOW, IT IS NOT POSSIBLE TO KNOW WHETHER OR NOT THESE BOTTLES WERE A TRUE POSITIVE, OR A FALSE POSITIVE. AT THE TIM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817638 ↗
• MalfunctionMar 1, 2024Device-Device Incompatibility; Device-Device Incompatibility

  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 AND FROM BLOOD PLATELET SAMPLES. IN BLOOD BANK FACILITIES, THE BACT/ALERT® VIRTUO® MICROBIAL DETECTION SYSTEM WILL PROVIDE IN-PROCESS TESTING FOR THE PRESENCE OR ABSENCE OF MICROORGANISMS. DESCRIPTION OF THE ISSUE. A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING A DELAYED RESULT WHEN USING THE VIRTUO, A UNIT - REFERENCE 411660 (SERIAL NUMBER# (B)(6)). THE CUSTOMER NOTIFIED THAT HE HAS TWO VIRTUO INSTRUMENTS : A VIRTUO AT LUTON AND A VIRTUO AT BEDFORD. IT IS UNDERSTOOD THAT POSITIVE BOTTLE RESULTS FROM LUTON HAVE NOT BEEN RECEIVED TO THE LABORATORY INFORMATION SYSTEM (LIS) AT BEDFORD WHERE THE BOTTLES ARE FURTHER TESTED. THE CUSTOMER INDICATED THAT THE GRAM STAINING HAS NOT BEEN PERFORMED FOR THESE BOTTLES BECAUSE BEDFORD SITE HAS NOT RECEIVED THESE BOTTLES. THEREFORE, FOR NOW, IT IS NOT POSSIBLE TO KNOW WHETHER OR NOT THESE BOTTLES WERE A TRUE POSITIVE, OR A FALSE POSITIVE. AT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817606 ↗
• MalfunctionFeb 6, 2024Mechanical Jam; Mechanical Jam

  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 AND FROM BLOOD PLATELET SAMPLES. ISSUE DESCRIPTION: A CUSTOMER IN FINLAND NOTIFIED BIOMÉRIEUX OF OBTAINING NO RESULT IN ASSOCIATION WITH THEIR VIRTUO® A UNIT (REF. (B)(4), SERIAL (B)(6). CUSTOMER REPORTED THEIR VIRTUO SECONDARY INSTRUMENT TO GIVE LOT OF ROBOT JAM ERRORS. THEY SAID IT OCCURRED SHORTLY AFTER INSTRUMENT HAS UNLOADED NEGATIVE BOTTLES. WHEN THEY OPENED THE INSTRUMENT DOOR TO FIX THE ERROR SYSTEM HAD CALIBRATION SLUG IN THE ROBOT HAND. CUSTOMER ALSO MENTIONED THAT THERE WAS A NOISE WHEN ROBOT MOVES BACK TO THE HOME POSITION (THEY ASSUME) WHICH IS SIMILAR TO THE NOISE WHEN BOTTLE IS UNLOADED TO THE RETRIEVAL AREA. THEY WERE WONDERING IF IT HITS SOMEWHERE. BIOMÉRIEUX FIELD SPECIALIST ENGINEER FOUND (B)(4) BOTTLES IN THE INSTRUMENT WHICH INSTRUMENT THOUGHT TO BE UNLOADED. GROWTH CURVE WAS ONLY CREATED FOR < 24 HOURS EVEN THOUGH BOTTLES HAVE BEEN INSIDE THE INSTRUMENT SINCE (B)(6) AND NO RES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648626 ↗
• MalfunctionJul 26, 2023False Negative Result; False Negative Result

  PRODUCT DESCRIPTION ********************** 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. COMPLAINT DESCRIPTION ************************* A CUSTOMER IN COLOMBIA COMPLAINED AFTER HAVING OBTAINED A FALSE NEGATIVE RESULT WITH THE VIRTUO, A UNIT (REF (B)(4), SERIAL NUMBER (B)(6). THE CUSTOMER SAID THAT THEY HAD INOCULATED A PATIENT'S SAMPLE (PERITONEAL LIQUID) ONTO BACT/ALERT FN PLUS BOTTLE AND THAT AFTER 9 DAYS OF INCUBATION THE BOTTLE WAS UNLOADED AS NEGATIVE. THE CUSTOMER REPORTED THAT THEY HAD INSPECTED THE BOTTLE AND FOUND THAT THE BOTTOM OF THE BOTTLE'S SENSOR WAS YELLOW, INDICATING THE BOTTLE TO BE POSITIVE THEREFORE THEY PERFORMED A GRAM STAIN AND HAD FOUND GRAM POSITIVE COCCI. THE CUSTOMER PERFORMED IDENTIFICATION TEST THAT CONFIRMED THE MICROOGANISM TO BE S. EPIDERMIDIS. NO FURTHER DETAILS WERE PROVIDED THE CUSTOMER STATES THAT THE CONCERNED PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17397175 ↗
• MalfunctionJun 28, 2023Communication or Transmission Problem; Communication or Transmission 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 AND FROM BLOOD PLATELET SAMPLES. ISSUE DESCRIPTION: A CUSTOMER IN SWEDEN NOTIFIED BIOMÉRIEUX OF OBTAINING NO RESULT IN ASSOCIATION WITH THEIR VIRTUO® A UNIT (REF. 411660, SERIAL (B)(6)). THIS COMPLAINT IS RELATED TO THE COMPLAINT (B)(4) (SAME CUSTOMER, SAME ISSUE, VIRTUO® A UNIT (REF. 411660, SERIAL (B)(6))). IT WAS REPORTED THAT CUSTOMER CAN¿T FIND TWO BOTTLES IN THEIR VIRTUO. BOTTLES WERE LOADED ON JUNE 3RD. THE INFORMATION FOR THESE BOTTLES HAS AGED OUT OF THE INSTRUMENT LOG FILES. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE SEARCHED FOR THE BOTTLES ON MYLA AND FOUND A RESULT RECORD FOR BOTTLE ID NR2LSBDD AND COULD ONLY FIND A LOAD EVENT RECORD FOR BOTTLE ID AR53MDJ8. THE RESULTS WERE AS FOLLOWS: BOTTLE ID AR53MDJ8: STATUS UNKNOWN BOTTLE ID NR2LSBDD: NEGATIVE IN THIS CONTEXT, DELAYED RESULT IS SUSPECTED BUT NOT CONFIRMED AT THE TIME OF THE GLOBAL ASSESSMENT. NO PATIENT HEALTH IMPACT HAS BEEN REPORTED DUE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218370 ↗
• MalfunctionJun 28, 2023Communication or Transmission Problem; Communication or Transmission 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 AND FROM BLOOD PLATELET SAMPLES. ISSUE DESCRIPTION: A CUSTOMER IN SWEDEN NOTIFIED BIOMÉRIEUX OF OBTAINING NO RESULT IN ASSOCIATION WITH THEIR VIRTUO® A UNIT (REF. (B)(4), SERIAL (B)(6)). IT WAS REPORTED THAT CUSTOMER CAN´T FIND BOTTLES IN THEIR VIRTUO, LAST ACTION FROM BOTH MYLA AND AUDIT TRAIL IS BOTTLE RELOADED 6/6. WHEN SEARCHING IN VIRTUO THERE IS NO RESULT FOR THE BOTTLE IDS MISSING. CUSTOMER IS CONCERNED ABOUT HOW THEY CAN FIND INFO OF THE BOTTLE, IF IT STAYED IN THE CELL 5 DAYS SO IT IS CONSIDERED NEGATIVE, OR IF IT WAS REMOVED BEFORE THAT. IN THIS CONTEXT, THE RESULT WAS DELAYED AS IT WAS MORE THAN 5 DAYS SINCE THE BOTTLES WERE LOADED. NO PATIENT HEALTH IMPACT HAS BEEN REPORTED DUE TO DELAYED RESULTS. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE REQUESTED ADDITIONAL INFORMATION TO UNDERSTAND WHY THESE BOTTLES CANNOT BE FOUND IN THE VIRTUO APPLICATION AND WHY THE INFORMATION WAS NOT SENT TO MYLA. AN I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218358 ↗
• MalfunctionDec 9, 2022Failure to Power Up; Failure to Power Up

  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: A BLOOD BANK CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A MALFUNCTION WITH THE VIRTUO, A UNIT (REF (B)(4), SERIAL NUMBER (B)(4)) THAT OCCURRED AFTER A PC REPLACEMENT AND WHICH LEAD TO DELAYED RESULTS GREATER THAN ONE DAY. THE CUSTOMER REPORTED THAT :¿PC WILL NOT BOOT. CYCLING POWER TO THE INSTRUMENT WAS UNSUCCESSFUL¿. A LOCAL FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND REPLACED THE PC. AFTER PC REPLACEMENT, THE EXISTING BOTTLES UNDER TEST UNLOADED. THE CUSTOMER RELOADED THE BOTTLES. AS A PRECAUTION, THE CUSTOMER WAS REQUIRED TO SUBCULTURE THE BOTTLES REMAINING IN THE INCUBATOR. AT THE TIME OF ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15948423 ↗
• MalfunctionAug 16, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  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 AND FROM BLOOD PLATELET SAMPLES.ISSUE DESCRIPTION:A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF A LACK OF RESULT FOR A MISSING BOTTLE IN ASSOCIATION WITH THEIR VIRTUO® A UNIT (REF. 411660, SERIAL (B)(4)) WHICH LED TO DELAYED RESULTS >24 HOURS.IT WAS REPORTED THAT A CUSTOMER HAD NO INFORMATION ON THE OUTCOME OF A PATIENT CULTURE BOTTLE THAT SHOULD HAVE COMPLETED TESTING. THE CUSTOMER STATED THE BOTTLE WAS LOADED ON THE (B)(6) IN THEIR VIRTUO INSTRUMENT AT 16:20 AND DOWNLOADED WITHOUT ANY RESULT AT 18:25. ACCORDING TO THE TECHNICIANS ON SHIFT, THE INSTRUMENT WOULD NOT ALLOW BOTTLES TO BE LOADED AND UNLOADED FROM THE INSTRUMENT; ASSISTANCE WAS CALLED AT APPROXIMATELY 17:45. IT WAS REPORTED THERE WAS GUIDANCE TO KEEP THE BOTTLES IN THE DARK AT ROOM TEMPERATURE UNTIL THE INSTRUMENT WAS UNLOCKED. THE NEXT MORNING, THE SITUATION SEEMED TO HAVE REMAINED THE SAME. A BIOMÉRIEUX FIELD SERVICE ENGINEER (FSE) CONNE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233983 ↗
• MalfunctionJul 12, 2022False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN CANADA NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE BOTTLE RESULTS FOR FIVE (5) PATIENTS WHEN USING THE BACT/ALERT VIRTUO A UNIT (REF.: 411660, SERIAL NUMBER: (B)(4)). BIOMÉRIEUX CUSTOMER SERVICE ANALYZED THE REPORTS AND IDENTIFIED THE EVENT AS FALSE POSITIVE RESULTS. THE RESULTS WERE AS FOLLOWS FOR EACH PATIENT (1 BOTTLE FA AND 1 BOTTLE FN PER ACCESSION NUMBER): PATIENT 1: ACCESSION NUMBER (B)(6). BOTTLE AR2P9K3F: RESULT IS NEGATIVE. BOTTLE NR0N5KWG: RESULT IS NEGATIVE, FLAGGED AS POSITIVE AFTER 2.7 - 2.8 HOURS. THE CUSTOMER APPROPRIATELY HANDLED THE BOTTLE BY RELOADING THE FALSE POSITIVE AS PER THE USER MANUAL. THERE WAS NO DELAY IN RESULTS, BASED ON LOG EVALUATION. PATIENT 2: ACCESSION NUMBER (B)(6). BOTTLE AR2PYYPM: RESULT IS POSITIVE. BOTTLE NR0N5KS2: RESULT IS POSITIVE. THE CUSTOMER APPROPRIATELY HANDLED THE BOTTLE BY RELOADING THE FALSE POSITIVE AS PER THE USER MANUAL. THERE WAS NO DELAY IN RESULTS, BASED ON LOG EVALUATION. THE CUSTOMER REPORTED THIS AS A TRUE POSITIVE. PATIENT 3: ACCESSION NUMBER (B)(6). BOTTLE AR2H60VV: RESULT IS NEGATIVE TO DATE. BOTTLE NR0N5K1Z: RESULT IS NEGATIVE TO DATE. CUSTOMER INDICATED THAT FOR THIS PATIENT, WHEN THE BOTTLE FLAGGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984420 ↗
• MalfunctionJul 12, 2022False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings; False Positive Result; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE BOTTLE RESULTS FOR FIVE (5) PATIENTS WHEN USING THE BACT/ALERT VIRTUO A UNIT (REF.: (B)(4), SERIAL NUMBER: (B)(4)). BIOMÉRIEUX CUSTOMER SERVICE ANALYZED THE REPORTS AND IDENTIFIED THE EVENT AS FALSE POSITIVE RESULTS. THE RESULTS WERE AS FOLLOWS FOR EACH PATIENT (1 BOTTLE FA AND 1 BOTTLE FN PER ACCESSION NUMBER): PATIENT 1: ACCESSION NUMBER 484984. BOTTLE AR2P9K3F: RESULT IS NEGATIVE. BOTTLE NR0N5KWG: RESULT IS NEGATIVE, FLAGGED AS POSITIVE AFTER 2.7 - 2.8 HOURS. THE CUSTOMER APPROPRIATELY HANDLED THE BOTTLE BY RELOADING THE FALSE POSITIVE AS PER THE USER MANUAL. THERE WAS NO DELAY IN RESULTS, BASED ON LOG EVALUATION. PATIENT 2: ACCESSION NUMBER 500323. BOTTLE AR2PYYPM: RESULT IS POSITIVE. BOTTLE NR0N5KS2: RESULT IS POSITIVE. THE CUSTOMER APPROPRIATELY HANDLED THE BOTTLE BY RELOADING THE FALSE POSITIVE AS PER THE USER MANUAL. THERE WAS NO DELAY IN RESULTS, BASED ON LOG EVALUATION. THE CUSTOMER REPORTED THIS AS A TRUE POSITIVE. PATIENT 3: ACCESSION NUMBER 493000. BOTTLE AR2H60VV: RESULT IS NEGATIVE TO DATE. BOTTLE NR0N5K1Z: RESULT IS NEGATIVE TO DATE. CUSTOMER INDICATED THAT FOR THIS PATIENT, WHEN THE BOTTLE FLAGGED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14984404 ↗
• MalfunctionFeb 22, 2022Failure to Obtain Sample; Failure to Obtain Sample

  ISSUE DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE IN WHICH A POSITIVE BACT/ALERT® BOTTLE (REFERENCE NOT PROVIDED) WAS REPORTED TO BE LOST IN THEIR VIRTUO® A UNIT (REF. 411660, SERIAL (B)(4)). DELAYED RESULT (>8 HOURS) WAS OBTAINED FOR ONE ¿MISSING BOTTLE¿. THE CUSTOMER STATED THAT THEY HAD AN ISSUE REGARDING A "MISSING BOTTLE". BIOMÉRIEUX¿S FSE (FIELD SYSTEM ENGINEER) VISITED THE CUSTOMER SITE AND IDENTIFIED THAT THEY HAD A CONNECTION ISSUE DUE TO THE FIREWALL AND ALSO A ROBOT JAM DURING CALIBRATION. THE FIREWALL AND CONNECTION ISSUES WERE RESOLVED, BUT BOTTLES HAD GOTTEN STUCK IN RACKS SO THE RACKS HAD TO BE DISABLED. THE FSE RESOLVED THE ISSUE WITH THE RACKS SO THE INSTRUMENT COULD BE FULLY USED AGAIN WITH ALL RACKS ENABLED. THE ISSUE WITH THE "MISSING BOTTLE" CAUSED A DELAY IN REPORTING RESULT OF A POSITIVE BOTTLE. IT WAS REPORTED THAT THERE WAS BLOOD CULTURE RESULT DELAYED MORE THAN 8 HOURS TO THE PHYSICIAN. THE CUSTOMER ALSO REPORTED THAT THE USERS OF THE INSTRUMENTS MAY HAVE BEEN EXPOSED TO BLOOD DUE TO BROKEN BOTTLES. IT WAS REPORTED THAT FOUR (4) BOTTLES WERE ANALYZED. THE THREE (3) THAT WERE NOT BROKEN GAVE A NEGATIVE RESULT. IN THE END T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13575784 ↗
• MalfunctionDec 3, 2021False Negative Result; False Negative Result

  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. DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE IN WHICH A BLOOD CULTURE BOTTLE WAS LEFT IN THE CUSTOMER'S VIRTUO, A UNIT (REF 411660, SERIAL (B)(4)) FOR NINE (9) DAYS WITH NO RESULT FOR THE BOTTLE (POTENTIAL FALSE NEGATIVE). THE CUSTOMER REPORTED THAT THE BOTTLE GRAPH LOOKS LIKE THE BOTTLE SHOULD BE POSITIVE FOR GROWTH AND THE THREE (3) OTHER BOTTLES ASSOCIATED WITH THIS PATIENT WERE ALL POSITIVE. DUE TO THE POSITIVE RESULTS OBTAINED FOR THE OTHER THREE (3) BOTTLES, THERE WAS NO DELAY IN REPORTING RESULTS TO THE TREATING PHYSICIAN. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12929108 ↗
• MalfunctionSep 7, 2021Failure to Obtain Sample; Failure to Obtain Sample

  DESCRIPTION OF THE PROBLEM: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE IN WHICH THE CUSTOMER FOUND DROPPED BACT/ALERT® BOTTLES (BOTTLE TYPE, REFERENCE NOT REPORTED) IN ASSOCIATION WITH THEIR VIRTUO® A UNIT (REF 411660, SERIAL (B)(4)). NO RESULT WAS OBTAINED FOR ONE DROPPED BOTTLE. THE CUSTOMER STATED THAT THEY FOUND THREE BLOOD CULTURE BOTTLES ON THE FLOOR OF THE VIRTUO INSTRUMENT. THE CUSTOMER STATED THESE BOTTLES HADN'T BEEN FLAGGED AS BEING DROPPED. GLOBAL CUSTOMER SERVICE (GCS) REVIEWED THE INSTRUMENT LOGS. FINAL GRAM STAIN/SMEAR RESULTS FOR EACH AFFECTED BOTTLE, AS WELL AS FINAL RESULTS OF MATE BOTTLES, WERE AS FOLLOWS: ALL GRAM STAINS NEGATIVE. MATE BOTTLE RESULTS: * 210445641AN = NO GROWTH AT 48 HRS, * 210445641AE = NO GROWTH AT 48 HRS, * 210431854AE = NO GROWTH AT 5 DAYS INCUBATION. BOTTLE 210431854 UNABLE TO PROVIDE ANAEROBIC BLOOD CULTURE RESULTS; THE ISSUE WAS IDENTIFIED TWO (2) WEEKS AFTER LOADING, LEADING TO DELAYED RESULT. A HISTORY OF ROBOTIC ARM FAILURE WAS EVIDENCED PRIOR TO THESE ERRORS, WHICH HAD BEEN PREVIOUSLY RESOLVED BY FIELD SERVICE ENGINEER (FSE). NO ERROR CODES WERE IDENTIFIED ON THE DAY OF LOADING OF AFFECTED BOTTLES. THERE IS NO IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436512 ↗
• MalfunctionAug 27, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  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 AND FROM BLOOD PLATELET SAMPLES. IN BLOOD BANK FACILITIES, THE BACT/ALERT® VIRTUO® MICROBIAL DETECTION SYSTEM WILL PROVIDE IN-PROCESS TESTING FOR THE PRESENCE OR ABSENCE OF MICROORGANISMS. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF EXPERIENCING AN INCREASE OF FALSE POSITIVE FA PLUS AND FN PLUS BOTTLES USING THE BACT/ALERT® VIRTUO® A UNIT (REFERENCE 411660, SERIAL NUMBER (B)(4), SOFTWARE VERSION (B)(4)). AT THE TIME OF THE CUSTOMER NOTIFICATION, IT WAS INDICATED THAT DURING THE MONTH OF (B)(6) 2021 APPROXIMATELY 300 CULTURE BOTTLES FROM VARIOUS BACT/ALERT BOTTLE LOTS WERE CONCERNED BY FALSE POSITIVE RESULTS. THE CUSTOMER WAS NOT WILLING TO COLLECT/PROVIDE DETAILS REGARDING THE NUMBER OF PATIENTS OR CLINICAL DECISIONS ASSOCIATED WITH THE IMPACTED CULTURE BOTTLES. THE CUSTOMER PERFORMED GRAM STAINING AND SUBCULTURE FOR BOTTLES FLAGGING POSITIVE. THEN, THE BOTTLES WERE RELOAD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379199 ↗
• MalfunctionJul 28, 2021Failure to Obtain Sample; Failure to Obtain Sample

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE IN WHICH THE CUSTOMER FOUND A DROPPED BACT/ALERT® BPN BOTTLE IN ASSOCIATION WITH THEIR VIRTUO® A UNIT (REF 411660, SERIAL (B)(4)). NO RESULT WAS OBTAINED FOR THE DROPPED BOTTLE. THE CUSTOMER STATED THAT THE BOTTLE WAS FOUND AT THE BOTTOM OF ONE OF THEIR VIRTUO MODULES. ACCORDING TO THE CUSTOMER, THE BOTTLE WAS LOADED ON (B)(6) 2021 AND THERE WAS A ROBOT JAM ERROR THAT OCCURRED AROUND THE TIME THIS BOTTLE WAS LOADED. GLOBAL CUSTOMER SERVICE (GCS) REVIEWED THE INSTRUMENT LOGS. GCS SEARCHED AND COULD NOT FIND THE BOTTLE IN QUESTION, (B)(4). GCS DID LOCATE INFORMATION IN THE AUDIT TRAIL FOR THE MATE BOTTLE, PATRDW74. THE MATE BOTTLE WAS LOADED ON (INSTRUMENT 4) SPC BANK2-B1 [SERIAL # (B)(4)). THE ERROR LOGS SHOWED NO JAMS OR ADVERSE EVENTS DURING THE INCUBATION PERIOD OF THE BOTTLE FOR INSTRUMENT (B)(4). THE INSTRUMENT IN WHICH THE MATE BOTTLE WAS LOADED DID HAVE A JAM BUT NOT A "DROPPED BOTTLE" ALARM. THE INSTRUMENT CONSTANTLY MONITORS THE STATUS OF WHERE BOTTLES RESIDE IN THE INSTRUMENT. IN THE EVENT A BOTTLE DID NOT MAKE IT TO ITS DESTINATION THERE WOULD BE AN ASSOCIATED DROPPED BOTTLE ALARM. THIS WAS NOT WITNESSED ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12238688 ↗
• MalfunctionJul 20, 2021Data Problem; Data Problem

  A CUSTOMER IN PORTUGAL NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WITH THEIR BACT/ALERT® VIRTUO¿ A UNIT (REF 411660, SERIAL (B)(4)) IN WHICH THE FINAL NEGATIVE RESULT FOR FOUR (4) BOTTLES BELONGING TO FOUR (4) DIFFERENT PATIENTS DID NOT TRANSFER TO MYLA® AND THE CUSTOMER'S LIS (LABORATORY INFORMATION SYSTEM). THE BOTTLES WERE FLAGGED NEGATIVE ON 01JUL2021 AT 01:03 AM AND THE VIRTUO AUTOMATICALLY UNLOADED THE BOTTLES AT 01:04 AM. THE FINAL NEGATIVE RESULTS WERE NOT SENT TO MYLA OR THE CUSTOMER'S LIS. LOCAL CUSTOMER SERVICE (LCS) CONFIRMED THAT THERE WAS A DELAY OF 36 HOURS IN REPORTING THE FINAL NEGATIVE RESULTS FOR THESE BOTTLES. LOCAL CUSTOMER SERVICE SENT THE NEGATIVE RESULTS FROM THE VIRTUO INSTRUMENT AND THE RESULTS UPDATED IN MYLA AND THE CUSTOMER'S LIS FROM NEGATIVE TO DATE (NTD) TO FINAL NEGATIVE. LCS CONFIRMED THAT THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197501 ↗
• MalfunctionJul 20, 2021Data Problem; Data Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WITH THEIR BACT/ALERT® VIRTUO¿ A UNIT (REF 411660, SERIAL (B)(4) ) IN WHICH THE FINAL NEGATIVE RESULT FOR FOUR (4) BOTTLES BELONGING TO FOUR (4) DIFFERENT PATIENTS DID NOT TRANSFER TO MYLA® AND THE CUSTOMER'S LIS (LABORATORY INFORMATION SYSTEM). THE BOTTLES WERE FLAGGED NEGATIVE ON (B)(6) 2021 AT 01:03 AM AND THE VIRTUO AUTOMATICALLY UNLOADED THE BOTTLES AT 01:04 AM. THE FINAL NEGATIVE RESULTS WERE NOT SENT TO MYLA OR THE CUSTOMER'S LIS. LOCAL CUSTOMER SERVICE (LCS) CONFIRMED THAT THERE WAS A DELAY OF 36 HOURS IN REPORTING THE FINAL NEGATIVE RESULTS FOR THESE BOTTLES. LOCAL CUSTOMER SERVICE SENT THE NEGATIVE RESULTS FROM THE VIRTUO INSTRUMENT AND THE RESULTS UPDATED IN MYLA AND THE CUSTOMER'S LIS FROM NEGATIVE TO DATE (NTD) TO FINAL NEGATIVE. LCS CONFIRMED THAT THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197497 ↗
• MalfunctionJul 20, 2021Data Problem; Data Problem

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WITH THEIR BACT/ALERT® VIRTUO¿ A UNIT (REF 411660, SERIAL (B)(4)) IN WHICH THE FINAL NEGATIVE RESULT FOR FOUR (4) BOTTLES BELONGING TO FOUR (4) DIFFERENT PATIENTS DID NOT TRANSFER TO MYLA® AND THE CUSTOMER'S LIS (LABORATORY INFORMATION SYSTEM). THE BOTTLES WERE FLAGGED NEGATIVE ON (B)(6) 2021 AT 01:03 AM AND THE VIRTUO AUTOMATICALLY UNLOADED THE BOTTLES AT 01:04 AM. THE FINAL NEGATIVE RESULTS WERE NOT SENT TO MYLA OR THE CUSTOMER'S LIS. LOCAL CUSTOMER SERVICE (LCS) CONFIRMED THAT THERE WAS A DELAY OF 36 HOURS IN REPORTING THE FINAL NEGATIVE RESULTS FOR THESE BOTTLES. LOCAL CUSTOMER SERVICE SENT THE NEGATIVE RESULTS FROM THE VIRTUO INSTRUMENT AND THE RESULTS UPDATED IN MYLA AND THE CUSTOMER'S LIS FROM NEGATIVE TO DATE (NTD) TO FINAL NEGATIVE. LCS CONFIRMED THAT THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197496 ↗
• MalfunctionJul 20, 2021Data Problem; Data Problem

  A CUSTOMER IN PORTUGAL NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WITH THEIR BACT/ALERT® VIRTUO¿ A UNIT (REF 411660, SERIAL (B)(4)) IN WHICH THE FINAL NEGATIVE RESULT FOR FOUR (4) BOTTLES BELONGING TO FOUR (4) DIFFERENT PATIENTS DID NOT TRANSFER TO MYLA® AND THE CUSTOMER'S LIS (LABORATORY INFORMATION SYSTEM). THE BOTTLES WERE FLAGGED NEGATIVE ON (B)(6) 2021 AT 01:03 AM AND THE VIRTUO AUTOMATICALLY UNLOADED THE BOTTLES AT 01:04 AM. THE FINAL NEGATIVE RESULTS WERE NOT SENT TO MYLA OR THE CUSTOMER'S LIS. LOCAL CUSTOMER SERVICE (LCS) CONFIRMED THAT THERE WAS A DELAY OF 36 HOURS IN REPORTING THE FINAL NEGATIVE RESULTS FOR THESE BOTTLES. LOCAL CUSTOMER SERVICE SENT THE NEGATIVE RESULTS FROM THE VIRTUO INSTRUMENT AND THE RESULTS UPDATED IN MYLA AND THE CUSTOMER'S LIS FROM NEGATIVE TO DATE (NTD) TO FINAL NEGATIVE. LCS CONFIRMED THAT THIS EVENT DID NOT LEAD TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12197490 ↗
• MalfunctionJul 8, 2021Missing Test Results; Missing Test Results

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF HAVING EXPERIENCED 'ERROR 55 - DATA INTEGRITY ERROR' MULTIPLE TIMES. THE CUSTOMER STATED THAT THEY ACKNOWLEDGE THE ERROR; HOWEVER, THE ERROR RETURNS. THE CUSTOMER PROVIDED THE DATA LOG TO BIOMÈRIEUX FOR EVALUATION. ANALYSIS OF THE CUSTOMER DATA WAS PERFORMED AND ON (B)(6) 2021; IT WAS OBSERVED THAT FOR TWO BOTTLES, RESULTS WERE MISSING. THE CUSTOMER CONFIRMED THAT, ON (B)(6) 2021, TWO (2) BOTTLES WERE UNLOADED AND NO RESULTS WERE PROVIDED BY THE SYSTEM. THE CUSTOMER STATED THAT THESE BOTTLES WERE TESTED MANUALLY AND NEGATIVE RESULTS WERE OBTAINED. ON (B)(6) 2021, THREE (3) ADDITIONAL BOTTLES WERE IDENTIFIED TO BE AFFECTED WITH THE ERROR. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE DESCRIBED ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMERIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12137869 ↗
• MalfunctionJun 14, 2021Missing Test Results; Missing Test Results

  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. DESCRIPTION OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A MALFUNCTION WITH THE VIRTUO, A UNIT (REF 411660, SERIAL NUMBER (B)(4) ) THAT OCCURRED DURING PREVENTIVE MAINTENANCE AND WHICH COULD LEAD TO POTENTIAL DELAYED RESULTS. A LOCAL FIELD SERVICE ENGINEER (FSE) REPLACED THE MASTER CONTROL BOARD (MCB) BATTERY OF THE VIRTUO, A UNIT. EVALUATION OF THE SYSTEM DATA LOGS INDICATED THAT THE DOOR OPENING DURING THE PREVENTIVE MAINTENANCE INADVERTENTLY CAUSED A DATE OFFSET, CHANGING THE DATE TO (B)(6) 2020 INSTEAD OF (B)(6) 2021. THIS LARGE TIME CHANGE CAUSED COMPUTATION ERRORS. CONSEQUENTLY, THE STATUS OF THE BOTTLES LOADED ON (B)(6) WAS NOT UPDATED FROM "NEGATIVE" TO "NEGATIVE TO DATE" AT THE END OF THE FIVE (5) DAYS OF INCUBATION. THE CUSTOMER WAS REQUIRED TO SUBCULTURE THE ASSOCIATED 127 BOTTLES. THE CUSTOMER SUBSEQUENTLY NOTIFIED BIOMÉRIEUX THAT THE ONLY BOTTLES AFFECTED WERE THOSE THAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995541 ↗
• MalfunctionDec 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WHERE RESULTS FROM TWO (2) BACT/ALERT® FA PLUS BOTTLES (REF 410851, LOT 0004054938) WERE NOT TRANSFERRED TO THE CUSTOMER'S LIS. THE CUSTOMER'S INSTRUMENT IS THE VIRTUO. A UNIT (REF 411660, SERIAL (B)(4)). THE SAMPLES WERE FROM TWO (2) DIFFERENT PATIENTS. THE BOTTLES WERE LOADED BEFORE THEIR EXPIRATION DATE (04NOV2020). THE CUSTOMER WAS AWARE THAT THE BOTTLES' EXPIRATION DATE WOULD OCCUR DURING THE INCUBATION PERIOD. USERS ARE INSTRUCTED IN THE PACKAGE INSERT (PI) TO NOT INOCULATE BOTTLES AFTER THE EXPIRATION DATE. SINCE THESE BOTTLES WERE LOADED PRIOR TO THE EXPIRATION DATE, THEY WERE INOCULATED PRIOR TO THE EXPIRATION DATE. THE CUSTOMER REPORTED THAT THE BOTTLES HAD COMPLETED THEIR INCUBATION TIME AND HAD BEEN UNLOADED. THE RESULTS COULD BE LOCATED ON THE VIRTUO UNIT ITSELF, BUT THE RESULTS HAD NOT BEEN TRANSFERRED TO MYLA®. THE BOTTLES SHOWED AS BEING STILL ON TEST. THE CUSTOMER INDICATED THAT THE ISSUE LED TO A DELAY IN REPORTING RESULTS TO THE PHYSICIAN BY ONE DAY LONGER THAN EXPECTED. ALTHOUGH THE RESULTS WERE DELAYED, THERE WAS NO PATIENT IMPACT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE RESUL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10995611 ↗
• MalfunctionDec 12, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF EXPERIENCING AN ISSUE WHERE RESULTS FROM TWO (2) BACT/ALERT® FA PLUS BOTTLES (REF 410851, LOT 0004054938) WERE NOT TRANSFERRED TO THE CUSTOMER'S LIS. THE CUSTOMER'S INSTRUMENT IS THE VIRTUO. A UNIT (REF 411660, SERIAL (B)(4)). THE SAMPLES WERE FROM TWO (2) DIFFERENT PATIENTS. THE BOTTLES WERE LOADED BEFORE THEIR EXPIRATION DATE (04NOV2020). THE CUSTOMER WAS AWARE THAT THE BOTTLES' EXPIRATION DATE WOULD OCCUR DURING THE INCUBATION PERIOD. USERS ARE INSTRUCTED IN THE PACKAGE INSERT (PI) TO NOT INOCULATE BOTTLES AFTER THE EXPIRATION DATE. SINCE THESE BOTTLES WERE LOADED PRIOR TO THE EXPIRATION DATE, THEY WERE INOCULATED PRIOR TO THE EXPIRATION DATE. THE CUSTOMER REPORTED THAT THE BOTTLES HAD COMPLETED THEIR INCUBATION TIME AND HAD BEEN UNLOADED. THE RESULTS COULD BE LOCATED ON THE VIRTUO UNIT ITSELF, BUT THE RESULTS HAD NOT BEEN TRANSFERRED TO MYLA®. THE BOTTLES SHOWED AS BEING STILL ON TEST. THE CUSTOMER INDICATED THAT THE ISSUE LED TO A DELAY IN REPORTING RESULTS TO THE PHYSICIAN BY ONE DAY LONGER THAN EXPECTED. ALTHOUGH THE RESULTS WERE DELAYED, THERE WAS NO PATIENT IMPACT. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE RESUL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10995586 ↗
• MalfunctionSep 30, 2020False Negative Result; False Negative Result

  A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE INSTRUMENT RESULT WITH A POSITIVE SUBCULTURE WHILE TESTING AN OCULAR FLUID SAMPLE USING THE VIRTUO® INSTRUMENT (REFERENCE # (B)(4), SERIAL # (B)(4)). THE CUSTOMER STATED THAT THEY RECEIVED ONE SAMPLE OF EYE FLUID IN TWO BLOOD CULTURE VIALS AND ONE CONTAINER. DIRECT CULTURE OF THE CONTAINER WAS IDENTIFIED AS STREPTOCOCCUS AGALACTIAE. THE INSTRUMENT UNLOADED THE BOTTLES AS NEGATIVE, BUT THE BOTTLE SENSORS WERE YELLOW INDICATING A POSITIVE RESULT. THE CUSTOMER SUBCULTURED BOTH BOTTLES, WHICH RESULTED IN THE GROWTH OF GRAM POSITIVE COCCI. THE BOTTLES WERE RECEIVED WITH LESS THAN 1 ML EYE FLUID, AND THE CUSTOMER DID NOT ADD ANY SUPPLEMENT OR HORSE BLOOD. PER THE PRODUCT PACKAGE INSERT, OPTIMAL RECOVERY OF ISOLATES WILL BE ACHIEVED BY ADDING MAXIMUM AMOUNTS OF SPECIMEN. USE OF LOWER VOLUMES MAY ADVERSELY AFFECT RECOVERY AND/OR DETECTION TIMES OF SOME ORGANISMS. IN ADDITION, BIOMÉRIEUX RECOMMENDS THAT INOCULATED CULTURE BOTTLES BE PLACED INTO THE BACT/ALERT MICROBIAL DETECTION SYSTEM AS SOON AS POSSIBLE AFTER COLLECTION. IF THERE IS AN UNAVOIDABLE DELAY, INOCULATED BOTTLES MAY BE MAINTAINED AT ROOM TEMPERATURE UP T

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10607485 ↗