MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 HP RP5800 PC-WES7

Model Number 413862

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux, of an issue regarding an inability to launch the vitek® 2 v8.01 software.Biomérieux collected the backup and log information via a secured link through vilink® to address the customer's software issues.The customer reported that all cards set up that day were lost.The customer reported that the cards were ejected remotely, and had to be set up again on the evening shift.The customer reported that there was delay greater than 24 hours in reporting results for one patient; but that there was no patient harm or indirect harm caused, incorrect treatment provided, or wrong results reported.There is no indication or report from a hospital or treating physician to biomérieux that the delayed result(s) 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 customer that updated to the vitek® 2 v8.01 software, and card data setup on (b)(6) 2019, was lost after the system was rebooted by the endofday process.This investigation revealed that a change in software behavior exists after upgrading to vitek 2 systems versions 8.01 and 9.01 where the network security certificates can become invalid.The conclusion of this investigation is that on the morning of 18mar2019, after the endofday process automatically rebooted the pc, the user experienced v2s web client logon failures and all currently running instrument messages were discarded and not processed because the vitek 2 systems software was unable to reach the biomerieux user management system (skeeper) due to a certificate that did not match the pc's host name.The specific system change that caused the failure is not known, but it is presumed to be a windows host name or network change (intentional or otherwise).An anomaly is known to exist in vitek 2 systems version 8.01 where if the web security certificates do not match the pc hostname or network ip address that instrument messages will be discarded and lost until the problem is resolved.Mar #4277 - vitek 2 systems 8.01 and higher-invalid security certificate, was issued on 17apr2019, to remind customers about the significance, and impact if they change the computer name and/or network configuration without a change control plan in place to regenerate security certificates.The mar provides information on how to diagnose and resolve the issue.

• Brand Name: VITEK 2 HP RP5800 PC-WES7
• Type of Device: VITEK 2 HP RP5800 PC-WES7
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: carma hodge ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 8520197
• MDR Text Key: 142356118
• Report Number: 1950204-2019-00101
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K0500002
• 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
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413862
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1