Intended use: vitek® ms prime 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 prime 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 and fungal infections.The vitek® ms prime system is intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.Issue description: a customer in the united states notified biomérieux of obtaining a misidentification of a corynebacterium species as brucella species in association with the vitek® ms prime (ref (b)(4), serial (b)(6)).The customer reported that they obtained an identification of brucella species with initial testing using the vitek ms prime.The identification to brucella species was unable to be reproduced and the organism was confirmed to be corynebacterium.Vitek ms prime: brucella species expected: corynebacterium species there is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health of the patient.An investigation will be initiated.
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An investigation was initiated in response to a customer complaint of obtaining a misidentification of a corynebacterium species as brucella species in association with the vitek® ms prime (ref (b)(4) , serial (b)(6).Complaint trend analysis: global customer service (gcs) performed a complaint trend analysis and did not identify the customer's issue as a trend for the vitek ms prime.Investigation: it was not possible to investigate regarding this specific misidentification because no data have been received.The customer declined to pursue an investigation and did not provide the data necessary to investigate the issue further.Root cause: the cause for the customer's issue could not be determined since the customer did not provide the strain for testing or any data for further analysis.Conclusion.The investigation could not find any evidence of a product performance issue.As the customer did not provide any strains or data for analysis, no further investigation could be completed.The customer's claimed issue of a misidentification of a corynebacterium as brucella has not been identified as a trend for the vitek ms prime.
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