MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

A customer in italy contacted biomérieux to report a misidentification of brucella melitensis as pseudomonas aeruginosa in association with the vitek® ms.Repeat testing with the vitek® ms produced the same identification.The customer tested the specimen (tss blood culture) with the vitek® 2, and the sample was identified as brucella melitensis.This vitek® 2 result was reported to the physician without delay, and there was no adverse impact to the patient's health.The customer stated the vitek® ms instrument was calibrated and fine tuning was performed on (b)(6) 2016.Biomerieux requested a culture sample, test reports from both vitek® systems, and the vitek® ms calibration and fine tuning analyzer reports.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: the result obtained by vitek® 2 (brucella melitensis) is not included in the vitek® ms v2.0 knowledge base (kb) (current version) or v3.0 (version under deployment).The sample was tested four (4) times on vitek® ms (two (2) different spots shot two (2) times).Three (3) tests gave "noid" and one test gave pseudomonas aeruginosa.Ecal mzml files were provided and analyzed.The most probable root cause to the misidentification obtained by the customer is a spot preparation issue.It has been observed during investigation that the number of "all peaks" is heterogeneous for e.Coli (calibrant strain) (between 67 to 124 peaks).Moreover, regarding the sample, the number of "all peaks" was lower at the second reading of the spot (from 71 to 55 for spot j3 and from 54 to 48 for spot j4).There is a system limitation when the tested species is not in the vitek® ms knowledge base.Vitek® ms system identification is based on a species pattern classification.The system limitation is due to the use of a predictive modeling based on a supervised learning.Typically, such a model includes an algorithm that learns certain properties (peaks presence) from a training spectra dataset in order to make those predictions.When the microorganism tested is not part of the training dataset, no specific species pattern will be available in the database for comparison.Consequently, the system can give: no identification (most probable answer) when the spectrum acquired doesn't match with any species pattern - obtained three (3) times on the four (4) tests performed a low discrimination identification (often the same genus than expected) when the spectrum acquired presents high level of similarity with multiple specific species patterns present in the database.An incorrect single choice identification to the nearest pattern species (often same genus than expected) when the spectrum acquired presents high level of similarity with a specific species pattern present in the database.Note: the kb user manual ref.161150-556- b for vitek® ms clinical use v3.0 mentions the following limitations: "testing of species not found in the database may result in an unidentified result or a misidentification.Note: 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.".

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX, SA; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6123257
• MDR Text Key: 60870341
• Report Number: 3002769706-2016-00486
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

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: No Information
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1