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

Model Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biom¿rieux of an organism misidenfication when using the vitek¿ ms instrument (ref.410895, s/n: (b)4).The vitek¿ ms instrument provided an organism identification to pseudomonas aeruginosa with 99.9% confidence when using the knowledge base (kb) 3.2.However, 16s rrna sequencing, which is the reference method, provided a result of pseudomonas nitroreducens.It is important to note that pseudomonas nitroreducens is absent from kb 3.0 and 3.2.There is no vitek¿ ms instrument claim for this species.Per the vitek¿ ms instrument instructions for use (ifu), "testing of unclaimed species may result in an unidentified result or a misidentification." there is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.

Manufacturer Narrative

An internal biomerieux investigation was performed following notification from a customer in china of obtaining a misidentification of pseudomonas nitroreducens as p.Aeruginosa in association with their vitek® ms instrument (ref.410895, serial number (b)(6)).The customer obtained three single choice results of p.Aeruginosa.They confirmed the organism identification, via 16s rrna sequencing, to be pseudomonas nitroreducens.Investigation: fine tuning: fine tuning status was good at the time of acquisition.However, one mandatory criteria was not achieved, which is a prerequisite for monitoring the system with vilink alert tool.Spot preparation quality: spot preparation of the sample appeared good, but the calibrator spot was not optimal.Calibrator ¿all peaks¿ values were heterogeneous.Knowledge base review: p.Nitroreducens is not present in the vitek® ms knowledge base v3.2, nor in the version (v3.3) currently under development.There is a vitek® version (saramis v4.16) which is for research use only.When the investigator ran the customer¿s data using the research version, they obtained a result of p.Nitroreducens.Sample data analysis: reprocessing the customer¿s data with vitek® ms knowledge base v3.2, all spectra led to a single choice of p.Aeruginosa.The following system limitation is noted in the vitek® ms v3.2 knowledge base user manual ref.161150-924-a: ¿* 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.¿ root cause: the information above shows the root cause to be a system limitation in that the organism species is not present in the knowledge base.Biomérieux assessed the risk associated with this issue and determined that the overall risk is irrelevant.A change request has been initiated for future vitek® ms knowledge base versions to include p.Nitroreducens.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11331821
• MDR Text Key: 256821405
• Report Number: 9615754-2021-00016
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• 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: 03/19/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1