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 the vitek ms instrument (ref.(b)(4), serial number (b)(4).Results are summarized below: vitek ms id: strep pneumoniae, reference lab (method unknown, report not available): s.Mitis; repeat testing on vitek ms: 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 the vitek ms instrument (ref.(b)(4), serial number (b)(6)) vitek ms mode : ivd.Kb version : 3.2 (cli).Vitek ms result: -single choice to streptococcus pneumoniae.-single choice to streptococcus mitis.Other method : vitek 2 by reference lab = streptococcus mitis.Expected id: suspected streptococcus mitis.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 04 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 not optimal.The calibrator ¿all peaks¿ values were heterogeneous.It needs to be verified with the customer.Kb review the suspected identification (streptococcus mitis) is present in vitek ms kb v3.2.Sample data analysis analyze of mzml sample files show that the identification was obtained with a negative score (-0.04).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator¿).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.Conclusion: non optimal spot preparation, off label used.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3 route de port michaud 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: 16067203
• MDR Text Key: 308538830
• Report Number: 9615754-2022-00151
• 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: 01/04/2023

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: 12/30/2022
• Supplement Dates FDA Received: 01/04/2023
• 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