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

Model Number 410895

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

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: a customer in austria notified the austria competent authority of misidentification of ochrobactrum as brucella species when using vitek ms instrument (b)(4).Customer indicated that they received one identification as brucella with 99.9 % of confidence.Customer indicated that the lab workers received an antibiotics prophylaxis due to the vitek ms result.The customer sent the strain to ages, and according to their pcr it is not a brucella.Ages is suspecting an ochrobactrum at the moment and no further information is available.Customer performed a gram staining, but the result is unknown at the moment.Summary: sample: throat swab.Vitek ms identification: brucella 99.9 % of confidence.Alternate method result: pcr ( ages): an ochrobactrum.Gram staining: result unknown.Biomérieux customer service indicated that a csn (customer service notification) was previously issued to customers in order to inform customer about potential misidentification as brucella spp with vitek ms kb3.2.These incorrect organism identifications have been observed in conjunction with degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue is resolved with the next vitek ms kb v3.3.Customer indicated that there was no negative effect on the patient but some users had to have prophylactic antibiotics prescribed as they were presumed to be potentially exposed to brucella.An investigation has been initiated.

Manufacturer Narrative

(b)(4) has been selected because users had to take preventive antibiotics following potential exposure to brucella species.Medication was therefore required as preventive treatment.

Manufacturer Narrative

Context: a customer in austria notified the austria competent authority of misidentification of ochrobactrum as brucella species when using vitek ms instrument (ref.410895, serial number : (b)(6)).Summary: sample : throat swab vitek ms identification: brucella 99,9 % of confidence.Alternate method result : pcr ( ages): an ochrobactrum gram staining: result unknown customer indicated that the lab workers received an antibiotics prophylaxis due to the vitek ms result.Investigation: batch history record and complaint trend analysis: there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results: fine tuning according to the vilink alert tool criteria, a fine tuning was needed during the customer¿s tests.Spot preparation quality the calibrator ¿all peaks¿ values are quite heterogeneous.Based on this finding, the spot preparation quality needs to be verified with the customer.Kb review unknown but customer is suspecting ochrobactrum species, no information about the species name.It could be a species out of the knowledge base.Sample data analysis the potential misidentification to brucella spp was obtained from the spectra having the lowest number of peaks (45).When the number of peaks is just over 30, the risk to get ¿doubtful¿ results is high due to a lack of information (missing peaks, not enough peaks to eliminate candidate identification).The other test gave no identification results with a highest number of peaks (64).Reprocessing the customer data with vitek ms kb v3.3 under construction also show that this new knowledge base allows to eliminate the misidentification to brucella spp.Both tests led to no identification results.In this case, the fine tuning status has drifted under the vilink alert tool criteria, it could be the most probable cause of the identification issue.A non-optimal sample spot preparation could also be a contributing factor.The issue will be fixed by the release of the next vitek ms kb v3.3.For information, the following limitation is mentioned in the user manual supplements - 161150-924 ¿ a ¿ en ¿ vitek ms clinical use - v3.2 knowledge base: 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.¿ testing of species not found in the database may result in an unidentified result or a misidentification.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.Based on these findings, further investigation on the strain is needed in order to confirm its identification.Related to the misidentification as brucella, csn # (b)(4) was published about potential misidentification as brucella spp with kb v3.2.These incorrect organism identifications have always been seen so far in conjunction with degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue will be fixed with the next vitek ms kb v3.3.Expected identification after investigation unknown conclusion: root causes analysis results: non optimal spot preparation.Fine tuning that has drifted under the vilink alert tool criteria.Kb weakness linked with the bad quality of spectra.

• 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
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme ; FR
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15909321
• MDR Text Key: 304782529
• Report Number: 9615754-2022-00142
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/02/2022
• Supplement Dates Manufacturer Received: 12/19/2022
• Supplement Dates FDA Received: 12/22/2022
• 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
• Patient Outcome(s): Required Intervention