MAUDE Adverse Event Report: BIOMERIEUX, S.A. VITEK® MS

Model Number 410895

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from russia reported to biomérieux a misidentification of salmonella typhimurium as escherichia coli for samples from two patients in association with the vitek® ms instrument (udi (b)(4)).The two patient samples of salmonella typhimurium were tested with vitek® ms and identified as escherichia coli.Each of the two samples were then tested with the reference sample, salmonella enteritidis, and the results were salmonella typhimurium.The reference sample, salmonella enteritidis was identified correctly with vitek® ms.The customer stated the incorrect result was not reported to the physician and the patient results and treatment were not impacted.The customer reported there was a delay in reporting results, but it was within the expected timeframe according to their procedure.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer reported misidentifications of salmonella typhimurium as escherichia coli for samples from two patients in association with the vitek® ms instrument (udi (b)(4)).An investigation was performed.Vitek ms result : e.Coli.Other identification method : serological tests confirmed salmonella.Expected identification : salmonella typhimurium.Sequencing: no.Orientation tests : unknown.Culture conditions : strains cultured simultaneously on the ss agar (biomerieux, shelf-life 2019-03-25, lot 1003917260) and levin-eosin-methylene blue agar medium (russia, shelf-life 06.2018) - colony selected typically for ss agar - without color, black middle.Issue date : 25&28 mar 2017.Last fine-tuning date : 24 apr 2017.Note: customer performed several tests for each patient sample: 11 isolates for patient id 008 and 13 isolates for patient id (b)(6).Conclusion on the system: 1.System was operational during the test (fine tuning acceptance criteria conformed).2.There was an heterogeneity observed for "all peaks" of the calibrant strain.So the spot preparation has to be checked with the user.However, this is not retained as a cause of the issue since the customer did a lot of tests (11 isolates for patient id (b)(6) and 13 isolates for patient id (b)(6).Conclusion on the identification: the most probable identification is salmonella typhimurium (confirmed by serological tests).It was not possible to confirm the identification by molecular method as the two customer's strains were not available for investigation.Suspected cause of the issue: the cause cannot be definitively defined (strains not available).However, based on all information provided, the most probable causes are: 1.Contamination of the chca matrix by e.Coli.2.Mixed culture because: the specimen is coming from feces (= polymicrobial population) the culture media used for the vitek ms test (ss agar ref.51043) has the following limitation "enterobacteria may produce characteristic colonies of salmonella and shigella".With vitek ms, shigella species are identified as e.Coli (as per vitek ms kb user manual 161150 - 556 -b paragraph limitations).

• Brand Name: VITEK® MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, S.A.; chemin de l orme; marcy l etoile, rhone 69280 ; FR 69280
• MDR Report Key: 6545786
• MDR Text Key: 74499179
• Report Number: 3002769706-2017-00089
• Device Sequence Number: 1
• Product Code: PEX
• Combination Product (y/n): N
• PMA/PMN Number: K124067
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410895
• Other Device ID Number: 03573026359119
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1