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

Model Number 411660

Device Problem Communication or Transmission Problem (2896)

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 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 to delayed results.Biomérieux global customer service requested additional information to understand why these bottles cannot be found in the virtuo app and why the information was not sent to myla.An investigation has been initiated.At the time of the global assessment, there is no indication or report from the customer that the no result led to any adverse event related to any patient's state of health.An investigation has been initiated.

Manufacturer Narrative

A customer in sweden notified biomérieux of obtaining no result in association with their virtuo® a unit (ref.411660, serial (b)(6).There are two clinical hospital customer site locations in sweden where these two a units are located so two complaint cases were created (cn-521004 and cn-523978).The two a units are connected together in a primary/secondary configuration using a myla® server, and they are located in different cities.The customer stated that ten (10) bottles were found in the hospital¿s lis (laboratory information system) that should have negative results by now as they are past 5 days old.There was no harm to any patient reported to the laboratory, but they could not request the details or further information from the physician without authorization.Investigation: *************** **capa and trend analysis** there are no containment or correction actions required by biomérieux.The issue is isolated to this one customer system, no adverse trend for this issue was found in the complaint or manufacturing data.No adverse trend was identified in the complaint database or manufacturing database related to this investigation.The bottles were found to have tested on the instrument and had final negative results.**investigation root cause analysis** the investigation involved reviewing instrument log files for the ten bottle ids provided by the customer as involved in this issue.The root cause of the issue is the customer ignoring persistent scheduled backup and purge failure alarms.When the scheduled backup has a failure, data is not purged from the system.Hence, the purge failure alarm.When data is not purged from the system, the size of the database grows.This led to the lack of free disc space on the virtuo pc e: drive, where the database lives, that caused the code 500 internal server errors.The recommended corrective action is to replace or reimage and restore the virtuo pc on the primary a-unit to factory settings.This recommendation was provided because the backup and purge failure alarms have been ongoing since 2021.A similar case of a purge failure from the same customer was reported on 13dec2021.The corrective action of replacing the primary a-unit virtuo pc was implemented at the customer site.The issue of lost bottles has not recurred since the pc replacement happened.The corrective action was completed, as the pc has been replaced by the field service engineer.The recommended preventive action is to address alarms as they appear and report persistent alarms to biomerieux immediately.Per the virtuo user manual the resolution for the backup and purge failure alarms state, ¿if the problem persists, contact your local biomerieux representative for assistance¿.Conclusion: ************* no specific harm to a patient was reported.The bottles were found to have tested on the instrument and had final negative results.No product malfunction was identified.The root cause is related to the user not responding to reoccurring instrument alarms for backup and purge failures.Once the database size reached its limit, the system performance was impacted.

Manufacturer Narrative

The mdr guidance, "medical device reporting for manufacturers, issued november 8, 2016", section 2.15, establishes that once a malfunction has caused or contributed to a death or serious injury, a presumption that the malfunction is likely to cause or contribute to a death or serious injury has been established.Biomérieux has performed a review and analysis of the mdr submissions, specific to the biomérieux bact/alert® reagents and virtuo® instrument.The review included mdrs submitted to the fda from 01-jan-2022 to 22-feb-2024.Based upon our review and analysis of biomérieux bact/alert® reagents and virtuo® instrument mdr submissions, there have been no customer claims of death or serious injury in the past two (2) years.Each has been investigated or is currently undergoing investigation, and any issues have been addressed by the manufacturing site.With the completion of our mdr data analysis, we have updated our mdr criteria for bact/alert® reagents and virtuo® instrument.Malfunction events for medical device problem code: a13, communication or transmission problem will no longer be reported for all bact/alert® reagents and virtuo® instrument (product codes: mdb, mzc) as these events are not "likely to cause or contribute to a death or serious injury" if they were to recur.Moving forward, if we become aware of a death or serious injury event related to nonstandard device results obtained with an bact/alert® reagents or virtuo® instrument, we will report that event to the fda per the fda mdr guidance and update our mdr criteria to include reporting the specific associated malfunction as required by the mdr guidance.

• 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: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 17218370
• MDR Text Key: 318072305
• Report Number: 1950204-2023-00006
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 03/13/2024

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: 06/26/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 08/31/2023; 02/27/2024
• Supplement Dates FDA Received: 09/05/2023; 03/13/2024
• 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