MAUDE Adverse Event Report: BIOMERIEUX, INC. BACT/ALERT® VIRTUO® INSTRUMENT

Model Number 411660

Device Problem Date/Time-Related Software Problem (2582)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a connection anomaly between the bact/alert® virtuo® instrument (reference (b)(4)) and the myla® server.The customer reported this anomaly was likely due to the daylight savings time change.No results were sent between virtuo and myla.There was a delay in negative-to-date results after 36 hours.There were 38 messages and three (3) pediatric patients.The impact of the negative to date messages is still under investigation by the customer.There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was performed for a connection anomaly between the bact/alert® virtuo® instrument (reference 411660) and the myla® server.A review of the instrument/software logs showed the problem was due to a network configuration change specific to one virtuo at the customer site.This change had broken the time server connection of virtuo, so the virtuo computer did not have the time synchronized with other systems and myla.After a period of time (week/month), this virtuo time drifted to more than 40 seconds (limit acceptable in myla), so myla raised the connection status to red, which stops generating and sending ntd message to the customer's lis.Myla worked as expected as the supervision screen warns the user by displaying a red virtuo connection status.On 31oct2018 11:44:37, the ntp (time server) was correctly reconfigured on the virtuo by the local field application specialist.The time synchronization between myla and virtuo is a key point highlighted in both the myla and virtuo service manuals: "4.9.2.3 configure time server between virtuo and myla" in "myla service manual" [4501-2129-n1] (version applicable to myla 4.5) "4.2.1.3 synchronizing myla and virtuo clocks" [514738-5en1_-_2017-07] (version applicable to virtuo r2) the troubleshooting is identified in the service manual in "8.2 errors and troubleshooting" in the "virtuo" section.

• Brand Name: BACT/ALERT® VIRTUO® INSTRUMENT
• Type of Device: BACT/ALERT® VIRTUO® INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: tiffany hall ; 100 rodolphe drive; durham, NC 27712 ; 9196203396
• MDR Report Key: 8102474
• MDR Text Key: 128405469
• Report Number: 1950204-2018-00579
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K161816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1