MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS PRIME®

Catalog Number 423281

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Event Description

Intended use; the vitek® ms systems a mass spectrometer using maldi-tof (matrix-assisted laser desorption/ionization-time of flight) technology for the identification of microorganisms cultured from clinical specimens.Description of the issue; a customer in netherlands notified biomérieux of obtaining a misidentification of pseudomonas species as brucella species 99.9% when using the vitek ms prime (reference (b)(4), serial numer (b)(6)).The customer indicated that the expected identification has been confirmed with a 16s sequencing.Summary: initial testing - vitek ms prime brucella species (99.9%) repeat testing - vitek ms prime brucella species (94.6%) alternate method testing - 16s sequencing pseudomonas species.At the time of the assessment, there is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Description of the issue a customer in netherlands notified biomérieux of obtaining a misidentification of pseudomonas species as brucella species 99.9% when using the vitek ms prime ( (reference (b)(4), serial numer) investigation results: **fine tuning** according to the vilink alert tool criteria, an auto fine tuning was needed during the tests made.Note : good fine tuning and good calibrator spot preparation are a prerequisite for monitoring the system with vilink alert tool.**spot preparation quality** the sample and calibrator ¿all peaks¿ values are quite homogeneous.**kb review** pseudomonas putida is present in vitek ms kb v3.2.However, pseudomonas entomophila and pseudomonas reidholzensis are not present.**sample data analysis** reprocessing the customer¿s data with new kb v3.3 show that this vitek ms knowledge base allows to eliminate the misidentification to brucella spp.All tests led to no identification results, it could be a species out of the knowledge base.Reprocessing the customer¿s data with ruo reference spectra data base vitek ms saramis v17 allows to identify one spectrum to pseudomonas fluva.This species is not present in any ivd knowledge base.It confirms that it could be a species out of our ivd knowledge bases.The analysis of the samples spots pictures show that the samples spots preparation are quite good.In addition, the analysis of customer¿s samples spectra with mmass indicates that the three spectra are quite similar and that intensity are also quite good.Investigation results: the investigation indicates that the fine tuning status seems to have drifted under the vilink alert tool criteria, it could be one of the most probable cause of the identification issue.Customer incubated the bacteria for 16 hours.For bacteria, the recommended incubation time written in vitek ms documentation is 18-72 hours.For reminder, our bacteria database have been built with the recommended incubation time written in vitek ms prime documentation.This is an ¿off label use¿ and it could modify the spectra content and consequently, it could affect the performances.The reprocessing of the customer data indicates that the potential strain could be pseudomonas entomophila and pseudomonas reidholzensis which are not present in vitek ms kb v3.2 and kb v3.3.For information, the following limitations are written in the user manual supplements - 161150-1611 - b - en - vitek ms prime clinical use - v3.2 knowledge base : * 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.¿ * brucella spp is an ¿highly pathogenic organism¿.Handle isolate with extreme caution and send it to a reference laboratory for further identification according to your laboratory¿s protocol and/or country regulations.The retained causes of the misidentification are the drift of the fine tuning status, the system limitation and the off label use.

• Brand Name: VITEK MS PRIME®
• Type of Device: VITEK MS PRIME®
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: pauline prévitali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17875515
• MDR Text Key: 324969048
• Report Number: 9615754-2023-00040
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K212461
• 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: 10/16/2023

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 Catalogue Number: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/11/2023
• Supplement Dates FDA Received: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1