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

Model Number 411660

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

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 results obtained were erroneous.An internal biomerieux investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in sweden regarding an issue where results from two (2) bact/alert® fa plus bottles (ref 410851, lot 0004054938) were not transferred to myla® or the customer's laboratory information system (lis).The customer's instrument is the virtuo.A unit (ref 411660, serial vrta-00247).The samples were from two (2) different patients.The customer reported that the bottles had completed their incubation time and had been unloaded.The bottle¿s negative 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.At the time of a botte load or reload, if the bottle will expire within the configured max test time duration, the expired bottle pop-up message will display.If the user selects continue test, the bottle will be processed by virtuo to obtain a result, and bottle updates including the result will be transmitted to myla or the lis.If the user selects to cancel test, the bottle test will be canceled and unloaded by virtuo.No bottle result is transmitted to myla or the lis until a user selects continue test on the expired bottle pop-up message.Virtuo backup data was received from the customer and was reviewed for the investigation.Bact/alert® fa plus bottle lot 0004054938 had an expiration date of 05nov20, and the bottle¿s incubation completion date was 04nov20.Immediately following the bottle load event, a message was received from myla with an updated max test time of 10 days.The new expected completion date was 09nov2020.This caused the bottle to expire within the new expected incubation period.Due to the max test time change occurring as a download from myla after the load event, the expired bottle alarm message did not display.Because the expired bottle pop-up message did not display, the user was not required to select continue test or cancel test and allow for transmission of results to myla or the lis.A software/firmware issue was identified as the root cause.This is a new software anomaly, #2961 ¿ bottle alarms not properly evaluated when bottle data changes as a result of a download from myla or the lis.It is present in virtuo software release 2 and release 3.The anomaly will be prioritized and addressed in a future software update.Biomérieux recommends customers using virtuo release 2 to refer to the bact/alert virtuo customer communication: 514944 - bact/alert virtuo system customer communication release 2.0 related to maximum test times, and the 4532 - fca ¿ product correction notice (bact/alert® virtuo® - maximum test time (mtt) anomaly).A customer service notification (csn-5090) and customer letter was released on 24-mar-2021 to inform virtuo release 3 users of the following actions: - view the virtuo software for the current status of the bottle, rather than myla or the customer lis.- make all modifications to max test time locally at the virtuo instrument to prevent this issue from occurring in the future.See section h10.

• 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: 10995611
• MDR Text Key: 247131103
• Report Number: 1950204-2020-00214
• 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: 03/30/2021

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: 11/11/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1