MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK® MS; VITEK MS INSTRUMENT

Catalog Number	410895
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mold infections.Issue description: a customer in the united states notified biomérieux of a misidentification of staphylococcus aureus as brucella spp.In association with the vitek® ms instrument (ref.(b)(4), serial number (b)(6)).The customer indicated that one patient sample was identified as brucella spp.Upon initial testing.Repeat testing resulted in an identification of staphylococcus aureus.At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Note: emily curran is under assessment qualification.The content of this assessment has been completed with the assistance of ben jost.Review and submission preformed by (b)(6).
Event or Problem Description
Intended use: vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mold infections.Issue description: a customer in the united states notified biomérieux of a misidentification of staphylococcus aureus as brucella spp.In association with the vitek® ms instrument (ref.(b)(4), serial number (b)(6)).The customer indicated that one patient sample was identified as brucella spp.Upon initial testing.Repeat testing resulted in an identification of staphylococcus aureus.At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Note: (b)(6) is under assessment qualification.The content of this assessment has been completed with the assistance of (b)(6).Review and submission preformed by (b)(6).
Additional Manufacturer Narrative
Vitek ms, mode: ivd, kb version: 3.2 (cli us), issue type: misidentification as brucella spp.Vitek ms result: single choice as brucella spp (data not provided).Other method: unknown.Expected id: unknown.Culture conditions: -culture media: unknown, - incubation: unknown, - spotting tool: unknown.Fine tuning date before the issue: unknown.Investigation 1.Complaint trend analysis and device history record: there is no trend.2.Investigation: the issue was already known to the customer (referenced in case (b)(4)), and an investigation ((b)(4)) had been conducted on this topic.As mentioned in the csn # (b)(4), the erroneous identifications of brucella were linked to a weakness in the knowledge base v3.2, consistently associated with degraded spectra, typically due to non-optimal spot preparation or non-optimal fine tuning - ft drifted.This issue was identified and resolved with the release of vitek ms knowledge base version 3.3.The current case was opened following a more recent incident reported by the customer.Although an update of the customer's knowledge base is currently being deployed, the customer chose to improve their spotting technique and acknowledged the limitations of version 3.2.Therefore, they did not wish to pursue further investigation, and it was agreed to close the case.3.Root cause analysis: - non-optimal spot preparation.- kb weakness linked with the bad quality of spectra.- non-optimal fine tuning.- fine tuning has drifted under the vilink alert tool criteria.4.Corrective or preventive actions: no capa number is needed.

• Brand Name: VITEK® MS
• Common Device Name: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: emily curran ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 18832749
• Report Number: 9615754-2024-00008
• Device Sequence Number: 7415429
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K181412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown