MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VTK2XL BLUE MOD COLORM 220V

Model Number 27228

Device Problem Output Problem (3005)

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

Event Type  malfunction  

Event Description

A customer in the (b)(6) notified biomérieux of obtaining delayed results >24 hours while using the product vtk2xl blue mod colorm 220v (ref.27228, serial number (b)(4)).It was reported that the customer had an issue with his vitek 2 system which led to delayed patient results without patient impact.The delay was over 24 hours.Despite several attempts to obtain additional information from the customer, biomérieux¿s global customer service doesn't know if there was any error message displayed to the customer on the instrument.In this situation, the results were in preliminary status with no further ability for the customer to resolve other than repeating the cards for testing after the fse (field system engineer) intervention/support.There is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

This investigation has been opened for complaints related to 'host communication' alarms and failures to process instrument messages into the vitek 2 software.The root cause determined in this investigation is due to the win defender updates causing a communication block between the vitek 2 system software and vitek 2 instruments.The resolution as part of this investigation is to apply the exclusion list per the existing "windows 10 network configuration guide (048640-02-info-4501)".Page 4-6 & 4-7 has the exceptions in the ¿installing antivirus software¿ section.This action was completed on (b)(6) 2022.

• Brand Name: VTK2XL BLUE MOD COLORM 220V
• Type of Device: VTK2XL BLUE MOD COLORM 220V
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO
• MDR Report Key: 13513886
• MDR Text Key: 288484566
• Report Number: 1950204-2022-00003
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N50510-084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1