MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT - 410895

Model Number 410895

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Issue description: a customer in the united states notified biomérieux of a misidentification of streptococcus mitis/streptococcus oralis as streptococcus pneumoniae in association with vitek ms instrument (ref.(b)(4), lot 50169).Alternate method testing was performed via vitek 2 with results of streptococcus mitis/streptococcus oralis.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 or any delay in treatment.

Event Description

Issue description: a customer in the united states notified biomérieux of a misidentification of streptococcus mitis/streptococcus oralis as streptococcus pneumoniae in association with vitek ms instrument (ref.(b)(4) lot 50169).Alternate method testing was performed via vitek 2 with results of streptococcus mitis/streptococcus oralis.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 or any delay in treatment.

Manufacturer Narrative

An investigation was initiated in response to one customer complaint relating to a misidentification of streptococcus mitis/streptococcus oralis as streptococcus pneumoniae in association with vitek ms instrument (ref.(b)(4), lot 50169).---investigation--- ***customer data review*** fine tuning: according to the vilink alert tool criteria, fine tuning was needed during the tests made on 11 nov 2022.This fine tuning was done the 15 nov 2022.Notes: -the variation of the curves observed on the two graphs (above) are due to ¿calibrator spot preparation variation¿ -good fine tuning and good calibrator spot preparation are a prerequisite for monitoring the system with vilink alert tool.Spot preparation quality: the calibrator ¿all peaks¿ values are quite heterogeneous.Based on this finding, the spot preparation quality needs to be verified kb review: streptococcus mitis/streptococcus oralis is present in vitek ms v3.0 and v3.2 but, it is not possible to verify because the knowledge base version was not provided.Sample data analysis: by reprocessing the customer data with vitek ms kb v3.2, two identifications are obtained to streptococcus pneumoniae and two to streptococcus mitis/ oralis.The two identified at streptococcus pneumoniae have less peaks than the two others done on 12 nov 22.By reprocessing the customer data with vitek ms kb v3.3, four low discrimination are obtained to streptococcus peroris / streptococcus pneumoniae or streptococcus peroris / streptococcus infantis / streptococcus mitis/ oralis or streptococcus peroris / streptococcus mitis/ oralis.By reprocessing the customer data with vitek ms kb saramis ruo 4.17, low discrimination to several streptococcus is obtained.The issue could be linked to a system limitation (species out of the vitek ms knowledge base).***root cause analysis*** to try to find the cause of the identification issues, a strains return has been asked.Unfortunately, the customer cannot provide us the strain.Consequently, no further investigation could be done and the cause of the issue has been defined as ¿unknown¿.---conclusion--- a single root cause was not identified.The customers strain was requested for investigation but the customer was unable to provide the strain and no further investigation could be performed.Global customer service (gcs) performed a complaint trend analysis and did not identify this issue as a trend.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK MS INSTRUMENT - 410895
• 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: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15934721
• MDR Text Key: 305665168
• Report Number: 9615754-2022-00145
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

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 Model Number: 410895
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/05/2023
• 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