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

Model Number 27228

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 not having visibility to isolates or cassettes in association with vitek® 2 software (b)(6).The customer loaded a cassette onto the vitek® 2 xl instrument, but could not locate the cassette or associated isolates using software (b)(6).The customer confirmed the cables were connected and stated no communication loss error message was provided.There is no indication or report from the laboratory that the instrument error 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 denmark regarding not having visibility to isolates or cassettes in association with vitek® 2 software version 8.01.The customer loaded a cassette onto the vitek® 2 xl instrument, but could not locate the cassette or associated isolates using software v8.01.Investigation conclusion: the review of the customer's vitek 2 systems software log files indicated a failure of the vitek 2 systems software coreserver service to start after the nightly end of day automatic reboot on 08-jan-2020.The cause of the failure of the vitek 2 systems software' coreserver service startup is not indicated by the provided software log files.Due to software log files did not contain any errors or reasons for the failure, the root cause of this event could not be adequately determined.Audible and visual alarms were continuously indicating communication failures (from (b)(6) 2020) between the instrument and the vitek 2 systems software pc.The log files contained evidence that on the morning of (b)(6) 2020 the instrument's communication alarms were acknowledged and subsequently resolved.The two cards mentioned in the complaint were then loaded a few hours later.However, the vitek 2 systems software was processing a backlog of messages from the instrument from 08-jan-2020 and 24-jan-2020, causing a delay in the cards to appear in the software.The delay would have been about 4 hours total, however the card/isolate results would not have been delayed.Root cause: not determined/unknown-the root cause of the coreserver service failure on 08-jan-2020 could not be determined.See section h10.

• 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
• MDR Report Key: 9741234
• MDR Text Key: 200608701
• Report Number: 1950204-2020-00017
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• PMA/PMN Number: S50510: S082
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• 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
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1