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

Model Number 410895

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event 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 canada notified biomérieux of misidentification of streptococcus mitis as streptococcus pneumoniae in association with vitek ms instrument (ref.(b)(4), serial number (b)(4)) results are summarized below: from 2 separate samples (same patient) vitek ms ids: streptococcus pneumoniae vitek 2 id: s.Mitis media and incubation: tsb with 5%sb, 16-24h co2.No patient harm reported.An investigation has been initiated.

Manufacturer Narrative

Context: a customer in canada notified biomérieux of misidentification of streptococcus mitis as streptococcus pneumoniae in association with vitek ms instrument (ref.(b)(4), serial number (b)(6)).Issue type : discrepant identification to streptococcus pneumoniae instead of streptococcus mitis for 2 separate samples id, same patient vitek ms result: sample 1 -single choice to streptococcus pneumoniae.Sample 2 -single choice to streptococcus pneumoniae.Other method: vitek 2 and reference lab = streptococcus mitis.Expected id: unknown.Culture conditions.-culture media : tsb with 5%sb.-incubation: 16-24 hours co2.-spotting tool: vitek pickme pen and nibs.Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results.*fine tuning according to the vilink alert tool criteria, fine tuning was not needed during the test made on 18 dec 2022.Note: good fine tuning and good calibrator spot preparation are a prerequisite for monitoring the system with vilink alert tool.Spot preparation quality the customer¿s spot preparation quality was good.The calibrator ¿all peaks¿ values were homogeneous kb review the suspected identification (streptococcus infantis) is not present in vitek ms kb v3.2.*sample data analysis reprocessing the customer data with vitek ms kb v3.3 allows to show that low discrimination results were obtained.Note : tests were made from a culture of 16 hours of incubation time, it is an ¿off label use¿.Recommended incubation time is 18h-72 hours for bacteria.In addition, as our bacteria database have been built with 18h-72 hours incubation time, using non validated incubation time could affect the performances.Biomérieux qc lab obtained 4 no identification and one mis identification to streptococcus mitis/streptococcus oxalis with vitek ms v3.0.Biomérieux global customer services (gcs) reprocessed the data and obtained no identification for all tests with vitek ms kb v3.2.Based on these results, the identification issue obtained by the customer was not reproduced internally by our biomérieux qc lab, the misidentification obtained by the customer seems to be linked to a non-optimal spot preparation.In addition, data have been reprocessed with vitek ms kb 3.3 and 5 identification to streptococcus infantis were obtained.Therefore, there is also a system limitation because it is a species out of vitek ms v3.2 knowledge base.However, streptococcus infantis has been added to the new vms knowledge base v3.3.The following system limitation is mentioned in the vitek ms v3.2 knowledge base user manual ref.161150-924-a: ¿* testing of species not found in the database may result in an unidentified result or a misidentification.Interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ conclusion: root cause analysis : system limitation -non optimal spot preparation.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: 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: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16067187
• MDR Text Key: 306715224
• Report Number: 9615754-2022-00150
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181412
• 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: 03/15/2023

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: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 03/10/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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