MAUDE Adverse Event Report: BIOMÉRIEUX, INC VITEK 2 V8.01 HP RP5810 PC WES7 - 421648

Catalog Number 421648

Device Problem Unable to Obtain Readings (1516)

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

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Intended use.Vitek® 2 systems and associated documentation are intended for laboratory use by trained, professional, clinical and industrial users.The vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and clinically significant yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non-fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Description: a customer in (b)(6) notified biomérieux of obtaining delayed results using the vitek 2 v8.01 hp rp5810 pc wes7 (reference # 421648, serial number # (b)(4)) due to an internal system error (during view cassette).The customer stated that the delay was >24 hours because ast results were not available, and the customer was required to repeat ast for concerned isolates.There is no adverse event related to any patient's state of health.An investigation will be initiated.

Manufacturer Narrative

On (b)(6) 2020, a customer in france (crm 30855144 / (b)(6)) notified biomérieux that results for tested isolates/cards did not appear in the expected time frame in association with their vitek 2 systems (v2s) software.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 from contact with biomerieux 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.Global customer service (gcs) bulletin 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 software maintenance release (9mr2) was released to the field on 03aug2021 via customer service notification (csn 5259 ¿ vitek 2 systems 9mr2 maintenance release) to allow editing of the setup tech name in applicable scenarios.

• Brand Name: VITEK 2 V8.01 HP RP5810 PC WES7 - 421648
• Type of Device: VITEK 2 V8.01 HP RP5810 PC WES7
• Manufacturer (Section D): BIOMÉRIEUX, INC; 595 anglum road; hazelwood MO
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11916227
• MDR Text Key: 273359921
• Report Number: 1950204-2021-00039
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103752
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 421648
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• 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