MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VTK2 60 BLUE MOD COLORM 220V - 27226

Model Number 27226

Device Problem Missing Test Results (3267)

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

Event Type  malfunction  

Event Description

Product intended use: vitek® 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast.The vitek® 2 utilizes growth-based biochemical patterns to determine identification.The vitek® 2 provides minimal inhibitory concentration (mic) results for most organism/drug combinations as well as a category interpretation (susceptible, intermediate, or resistant) consistent with accepted criteria.Description of the issue: a customer from norway reported that they experienced some vitek 2 results that do not appear in the cassette list when using the vitek 2 instrument vtk2 60 (ref.27226) ¿ serial number (b)(4).The customer reported that they observed this issue when they placed samples into the vitek 2 instrument, and when checking for results the following day, the samples did not appear in the software.The customer also reported that, at times, the missing sample information will subsequently appear in the system after 2 or 3 days.The number of impacted samples was not indicated by the customer.There is no indication from the customer that these events impacted any patient's states of health.

Manufacturer Narrative

A customer from norway reported that they experienced some vitek® 2 results that do not appear in the cassette list when using the vitek 2 instrument vtk2 60 (ref.27226) ¿ serial number (b)(6).Customers whose systems exhibit the inability to access the vitek 2 systems web client caused by an invalid certificate should run the certificate scripts in vitek® 2 systems software to resolve the condition.Biomérieux global customer service (gcs) notification mar 4277, issued 17apr2019, includes steps to prevent this issue and includes necessary steps to resolve the invalid https certificates if encountered.This anomaly is resolved in vitek® 2 systems software versions 9.01.1 and 9.02.Biomérieux recommends for customers to consider upgrading to vitek® 2 systems software versions 9.01.1 or 9.02 to prevent the loss of card data and future occurrences of this anomaly.Additionally, a software maintenance release was launched on 03aug2021 to address this issue.

• Brand Name: VTK2 60 BLUE MOD COLORM 220V - 27226
• Type of Device: VTK2 60 BLUE MOD COLORM 220V
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12050502
• MDR Text Key: 273363690
• Report Number: 1950204-2021-00041
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: N50510/082
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• 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: A
• Patient Sequence Number: 1