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

Model Number 411660

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a premature bottle discharge in association with their bact/alert®-virtuo® system (ref.4703336), stating the bottle was discharged from the instrument after five (5) days of incubation.The customer stated the bottle was set to incubate for fourteen (14) days for a red blood cell sterility test from a cytapheresis sample.There was no error message or notification associated with the premature bottle discharge.Subculture of the bottle was not performed.There is no indication or report from the laboratory that the premature bottle discharge led to any adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in france regarding a premature bottle discharge in association with their bact/alert®-virtuo® system (ref.(b)(4)), stating the bottle was discharged from the instrument after five (5) days of incubation.The bottle was set to incubate for fourteen (14) days.An internal investigation was conducted analyzing the instruments log files.The review concluded the root cause of the issue was a timing condition.Once the bottle data is scanned and identified by the instrument, myla immediately downloads the bottle message that contains the maximum test time (mtt) change.Ample amount of time was not allowed for the master control board (mcb) to correctly interpret the mtt change.This anomaly has been addressed and not present in the upcoming virtuo® 3.0 version.Field correction action (fca) 4532 was issued informing customers of the identified maximum test time anomaly associated with the bact/alert®virtuo® system release 2.0.

• 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: 10080540
• MDR Text Key: 203145971
• Report Number: 1950204-2020-00132
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 05/11/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 07/09/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1