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

Model Number 411660

Device Problem Missing Test Results (3267)

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

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

An investigation was conducted for one customer complaint for bact/alert® virtuo® serial number (b)(6) version r3 in a standalone configuration.An alarm for (55) software data integrity error occurred in the days after the system was updated to r3 by the biomérieux field service engineer.The investigation found the root cause for the (55) software data integrity error was a software anomaly involving a bottle record that had the same accession number on two bottles, but for one bottle the letter was uppercase and for the other bottle was lowercase.This error caused the record not be recognized as the same, and one of the bottles was an orphan record in that it had no patient information associated with it.This new software anomaly was documented under helix #2984 and will be prioritized to be addressed in a future software update.See record involved in the error listed below: specimen m207622 is associated with sn (b)(6) loaded on (b)(6) 2021 3:58 pm.Specimen m207622 is associated with sawstjyh loaded on (b)(6) 2021 4:00 pm.After the r3 update, the alarm occurred when the bottle result updated to negative, and caused the bottle to be unloaded to the front bottle retrieval pad on virtuo.The alarm is visual and audible, and therefore highly detectable.Due to the data integrity error, the bottle result was not able to be displayed in the virtuo pc (large screen).The bottles involved in this error do test normally and have their readings processed by the mcb (master control board) with results displayed on the mcb's small screen at the time of the unload.The customer was able to see on the small screen when the bottle automatically unloaded that the bottle involved in this incident was negative.Since there is no result in the virtuo pc, the result is not transmitted via interface to the customer's lis (laboratory information system).The customer manually entered the bottle result in their lis.No harm to any patient for this complaint was reported.Biomérieux in-house testing reproduced the complaint.Positive and negative bottles under test during the update that have the accession discrepancy will behave the same to unload to the front bottle retrieval pad when their status changes and with the result seen on the small screen.Positive bottles will still alarm visually on the ssi light at the top of the instrument, and audibly (i.E.Beeping).The issue does not occur for bottles that were not under test at the time of the r3 update (i.E.Historical records in the database).The bottle instructions for use (ifu), and bact/alert virtuo user manual, were reviewed by the investigator and found to have adequate directions for the user.Queries of the manufacturing data, and the complaint data do not reveal any adverse trend for the (55) software data integrity error.The error may occur on systems with standalone configuration as this configuration allows users to manually enter and edit accession numbers.Other system configurations (primary/secondary, multi-instance) use a myla® server and therefore records are not manually entered at virtuo.When the alarm for (55) software data integrity error occurs, the alarm can be dismissed but will reoccur until the record is corrected.Changing the accession numbers to a new value will correct the error, and prevent the alarm from reoccurring.Since the bottle is unloaded to the front bottle retrieval pad, it can be handled and addressed immediately by the customer.Biomérieux recommends the customer always resolve anonymous and orphan bottle records daily.The bottles involved in this anomaly would have been present on the orphan icon on the main screen and the orphan bottle report.Biomérieux will notify the field service engineers via a customer service notification (csn 5296- bactalert virtuo standalone r3 update anomaly for orphan bottles) to check for orphan bottles and have the customer resolve them before performing a software update on virtuo.The investigation recommended the r3 update instructions be updated to include to check and resolve orphan bottles prior to starting the update (helix #2990).

• Brand Name: VIRTUO, A UNIT
• Type of Device: VIRTUO, A UNIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 12137869
• MDR Text Key: 273360678
• Report Number: 1950204-2021-00043
• 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: 09/30/2021

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: 06/11/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1