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

Model Number 411660

Device Problem Data Problem (3196)

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

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

An investigation was conducted for one customer complaint for bact/alert® virtuo® serial number (b)(6) version r3 in a site configuration with myla® server version 4.7.1.After the monthly reboot of the virtuo pc at the first of the month on (b)(6) 2021, the customer noticed four bottle records did not update in myla to final negative, see list of the bottle ids below.Prwcwwzt, arzdrg84, arzdg8d7, nryh4bpv.The investigation could not identify the root cause or reproduce the issue with in-house testing.The most likely root cause would be an issue with the myla connector component related to a race condition with the myla monthly reboot and virtuo result messages occurring at the same time.The issue is isolated, and low risk to the patients as any records in myla missing their final result can be updated by pressing the upload button at virtuo.In this complaint case the bottle results were negative.If the bottle results were positive, the positive bottles would be unloaded from virtuo and the gram stain resulted in the lis and possibly called to the physician; therefore also a low risk to impact the patient.The customer noticed the four bottle records still showed a result of negative to date in myla, when they should have been final negative.Their immediate action was to call local customer service, who advised them to resend the results by pressing the upload button on the virtuo bottle record.No specific harm or impact to the two patients was stated.The bact/alert virtuo user manual was reviewed by the investigator and found to have adequate directions for the user.The manual describes use of the upload button to resend bottle records to myla.Queries of the manufacturing data and the complaint data do not reveal any adverse trend.For the complaint data the error code virtuo/myla interface problem - k056 was reviewed.This error code may be used for various issues, but no other complaints for records not updating after the first of the month virtuo pc reboot were found in the last 13 months.Global customer service recommends the customer check the myla results daily and press the upload button on virtuo¿s bottle record when they notice any results not updated on myla.Pending negative to date bottle results past their maximum test time can be targeted.Global customer service also recommends the customer notify biomérieux if the issue reoccurs.Biomérieux will continue to monitor complaints for this issue.

• Brand Name: VIRTUO, A UNIT
• Type of Device: VIRTUO®, A UNIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 12197490
• MDR Text Key: 281980475
• Report Number: 1950204-2021-00045
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• PMA/PMN Number: K161816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/20/2021
• Supplement Dates Manufacturer Received: 09/15/2021
• Supplement Dates FDA Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1