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

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 mould infections.Issue description: an customer in israel reported to biomérieux potential misidentifications for three samples in association with the product vitek ms instrument (ref.(b)(4), serial number (b)(4).It was reported that the customer obtained discrepant results between vitek ms and a public health office laboratory.The customer stated that the results provided by vitek ms were corynebacterium diphtheriaea but when they sent the culture to the public health office, the results were different.It is understood that the customer suspected a vitek ms misidentification.Biomérieux global customer service requested additional information to the customer to further investigate the case.At the time of the global assessment, there is no indication or report from the customer that this event led to any adverse event related to the user/patient's state of health.An investigation has been initiated.

Manufacturer Narrative

Context: a customer in israel reported to biomérieux potential misidentifications for three samples in association with the product vitek ms instrument (ref.(b)(4), serial number (b)(6)).Vitek ms mode : ivd kb version : v3.2 (cli) issue type : 3 discrepant identification issues on corynebacterium diphtheriae involving vitek ms instrument vitek ms results: sample (b)(6): 04 and 06 nov 22: single choice to corynebacterium diphtheriae other methods: vitek 2 gave twice rothia kristinae sample (b)(6) and (b)(6): 14 and 17 nov 22: single choice to corynebacterium diphtheriae other methods: vitek 2 gave twice pseudomonas aeruginosa sample (b)(6) and (b)(6): 14 and 17 nov 22 single choice to corynebacterium diphtheriae other methods: vitek 2 gave twice pseudomonas aeruginosa expected id: unknown, in the complaint it was mentioned that samples were sent to public health office but no results provided.Culture conditions: -specimen: unknown -culture media: tsab -incubation: 18 to 24 hours -spotting tool: loop issue date: 04, 06, 14 and 17 nov 22 fine tuning date before the issue: -unknown for tests made on (b)(6) 2022 -on (b)(6) 2022 for tests made on (b)(6) 2022 investigation: 1.Complaint trend analysis and device history record no trend analysis has been done because the identification appears to be the correct one.There is no capa, no non-conformity on vitek ms linked with customer 's complaint.2.Investigation results *fine tuning according to the vilink alert tool criteria, no fine tuning was needed during the tests made between (b)(6) 2022.*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 based on complaint description the expected identification is corynebacterium diphtheriae which is in the vitek ms knowledge base *sample data analysis reprocessing the customer data with vitek ms kb v3.2 allows to obtained corynebacterium diphteriae for the three samples with good level of peaks and good level of identification the analysis of customer¿s data highlights no malfunction.Vitek ms system identified customer¿s strains as corynebacterium diphteriae.*expected identification after investigation corynebacterium diphteriae conclusion: the analysis of the root cause concluded there was no malfunction.There is no reconsideration of the performance of vitek ms instrument (ref.(b)(4), serial number (b)(6)).

• Brand Name: VITEK® MS
• 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: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 16012400
• MDR Text Key: 308528702
• Report Number: 9615754-2022-00148
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 02/21/2023

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
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/20/2022
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/21/2023
• 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