MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VIRTUO, A UNIT

Model Number 411660

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

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) connected and the instrument started again.The highlighted problem was that in the hours in which the instrument was inaccessible, the bottle in question appeared to have been discharged.The customer claimed the loss of the bottle information and the result of the examination.The missing bottle has not been located.It was reported that the anaerobic bottle linked to the lost bottle was negative.However, a linked bottle pair taken on the same day provided positive bottle results.There is disparity in the customer's report, as it was also reported by the customer that, per original case notes, the mate bottle was positive (not negative).According to biomérieux global customer service (gcs) analysis, if the instrument was not loading or unloading bottles as mentioned, an alarm may have been logged/displayed on the software.It was requested to the customer if the virtuo showed specifically error 86 (86) negative to date bottle removed - k125.After several attempts to gain additional information and clarification, the following detail was provided by the customer: in the previous 24 hours there was a technical problem on the virtuo and therefore the bottles were not unloaded manually.It was reported that the customer does not even know if this bottle really had ever "existed" and that the bottle was potentially never processed.Gcs is waiting for logs data to confirm if the bottle was loaded or not.It was reported that there were no adverse consequences because the lab sent another aerobic (aer)/anaerobic (anaer) collection set (one bottle for aer and one bottle for anaer) for blood culture and the bottles results were negative.In this situation, it was reported that there were delayed results with a duration greater than 24 hours.There is no indication or report from the customer that this event led to any adverse event related to the patient's/user¿s state of health.An internal investigation has been initiated.

Manufacturer Narrative

Context: a customer in italy notified biomérieux of a lack of result for a missing bottle in association with their virtuo® a unit (ref.(b)(4), serial (b)(6)) which led to delayed results >24 hours.Investigation: batch history record and trend analysis.The batch record was verified.Non-conformances during manufacturing and during our quality control processes that could explain the issue were not identified.There is no capa related to the customer¿s complaint recorded.A complaint history review completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results the immediate action by the customer is unknown, the bottle was loaded on 05jul2022 and the customer contacted biomérieux about this bottle on 28jul2022 because the bottle had no result on the virtuo instrument.The immediate action by local customer service (lcs) was to gather instrument data for the bottle record ar29jc2p, and escalate the case to global customer service (gcs) on 28jul2022 for assistance.The data showed the bottle was first loaded on 05jul2022 and manually unloaded 2 hours after the first load.A root cause could not be determined.The logs containing the instrument activity for the date of occurrence were not available for this investigation.Pertinent log information and dates of interest were beyond the retention for instrument serial number (b)(6) at the time the backup and logs were collected.Due to the delay in obtaining instrument files, the investigator was unable to conduct a full review of instrument events, and therefore cannot provide a satisfactory root cause for the reported bottle issue.Although a root cause could not be determined, biomérieux recommends the customer instruct the lab personnel to review user manual procedures for alarm code (7) dropped bottle events.The log files did show that an "instrument alarm dropped bottle" did occur at the same time the bottle ar29jc2p was manually unloaded.Virtuo microbial detection system user manual (050574-01) directs users to address instrument alarms by opening the instrument door and inspect the areas that may contain a bottle or calibration standard such as: bottom of instrument, robot gripper, retrieval chute, cell containing an unseated bottle or calibration standard, and waste chute.When found, the bottle should be reloaded on the conveyor.Based on customer comments in the complaint record and date of notification of alleged missing bottle, the site technician did not follow user manual recommendations to solve the bottle alarm.If no bottle or calibration standard was found, then it is possible that it was placed in a cell, but was not seated well enough to be detected by the instrument.After closing the door, the robot will attempt to unload from the intended cell.If a bottle or calibration standard is found by the robot, the bottle found in unavailable cell alarm occurs and it is returned to the retrieval area.Solutions for alarm code (7) bottle dropped also include removing stuck labels, as well as cleaning the gripper jaws, calibration slugs, and conveyor belt.Occasionally, ensuring the calibration slugs are in the correct location, or replacing the gripper jaws, pads, and/or springs can correct this error.In the most extreme circumstances, rebooting the mcb (master control board or small screen) can also solve this issue.Additionally, the customer should continue to observe that no more than 70 bottles are loaded in a 1-hour period and that batches do not exceed 40 bottles (20 bottles is optimal), ensuring their loading process is complete and the conveyor belt area cleared.Conclusion: queries of the manufacturing data, and the complaint data do not reveal any adverse trend for any issue related to lost negative to date bottles.The investigator reviewed the virtuo user manual and found the instructions for use are adequate.Biomérieux's global customer service made these recommendations: check the reports for unloaded bottles daily and if any bottles have ¿negative to date¿ results then ensure all ¿negative to date¿ bottles have been reloaded appropriately check the final negative bottle report daily for any discrepancies, such as a missing mate bottle result.Check that all instrument alarms are addressed appropriately by staff (they can be found in the audit trail).Since no bottle was found in the bottom of the instrument, and the data that was able to be reviewed from the instrument indicates the bottle was manually unloaded and never reloaded: instruct staff to always manually record any manually unloaded bottle by removing the pull tab and putting it on a paper log for traceability, place bottle in a designated spot until it can be reloaded so it doesn¿t get lost.Instruct staff that any manually retrieved bottle must be promptly reloaded to continue testing on the instrument to avoid a lost or delayed result: this includes bottles manually pulled out of cells as well as bottles picked up from the floor of the instrument.Review the virtuo user manual troubleshooting section for dropped bottle alarm and the emergency manual load/unload section for handling of manually unloaded bottles capture the instrument logs and backup as soon as possible after an issue occurs to ensure the data is present for analysis.

• Brand Name: VIRTUO, A UNIT
• Type of Device: VIRTUO, A UNIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15233983
• MDR Text Key: 305344475
• Report Number: 1950204-2022-00025
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K161816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 411660
• Device Catalogue Number: 411660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/16/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1