MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 XL BLUE MOD COLORM

Model Number 27228

Device Problem Missing Test Results (3267)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomerieux of a delay in obtaining results for a patient isolate in association with the vitek® 2 computer in association with their vitek® 2 xl (ref.27228) and software version 8.01.The isolate was initially tested on (b)(6) 2020, the customer stated the isolate should have appeared on their vitek® 2 web application the following day (b)(6) 2020.The isolate was not present when the customer opened the version 8.01 web application.The isolate was retested on (b)(6) 2020; results transferred and were read by the customer on (b)(6) 2020.The customer stated the result should have been available on (b)(6) 2020, and that there was a delay in reporting results greater than twenty-four (24) hours because the isolate was retested.There is no indication or report from the laboratory that the delay in results led to any adverse event in the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

On 09nov2020, a customer in france ((b)(6)) reported that in vitek 2 systems (v2s) software, results for tested isolates/cards did not appear in the expected time frame.There were no errors displayed to the customer.The customer reported that setting up new cards and running test again did provide results.The issue began when the customer¿s system was at vitek 2 system software version 8.01 and continued after upgrading to vitek 2 systems software 9.02.The investigation identified (2) root causes: invalid certificates prevented vitek 2 software to contact biomérieux user management (skeeper) when a cassette was processed.Error of the user for entering setup tech name incorrectly.This prevented the cassette (isolate) results from appearing in the v2s software.Gcs mar ¿4277, vitek 2 systems 8.01 and higher-invalid security certificate - computer name or network configuration change¿ was issued on 17apr2019 to remind subsidiaries/distributors and customers about the instructions for modifying the pc hostname or network configuration.A maintenance release (9mr2) was issued to the field on 03aug2021 via customer service notification (csn 5259 ¿ vitek 2 systems 9mr2 maintenance release) to correct the problem of not being able to edit the setup tech name in applicable scenarios.Biomérieux highly recommends that customers apply 9mr2.If the customer chooses not to apply 9mr2, the customer will not be able to correct setup tech errors.

• Brand Name: VITEK® 2 XL BLUE MOD COLORM
• Type of Device: VITEK® 2 XL BLUE MOD COLORM
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10972476
• MDR Text Key: 225573865
• Report Number: 1950204-2020-00211
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N50510: S082
• 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: 11/12/2021

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: 27228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 10/22/2021
• Supplement Dates FDA Received: 11/12/2021
• 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