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

Catalog Number	410895
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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 portugal reported to biomérieux a potential misidentification as brucella spp in association with the product vitek ms instrument ref (b)(4), serial number (b)(6) with a sample.Customer has obtained a doubtful brucella spp.Identification for a rod-shaped gram positive microorganism.As it was seen in the reports, the first attempt gave brucella spp/ bacillus cereus group low discrimination.After that, there was a brucella spp 99,9% result.Finally, for the third attempt, they obtained no id result due to bad spectrum.Incubation was 48h, 30-35ºc in tsa plate.At the time of the global assessment, the expected result is not confirmed, the customer was still considering if they want to send this sample for external analysis.Per biomérieux global customer service, additional investigation is needed to confirm the strain identification, a potential user error and the potential root cause of the vitek ms result.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 will be initiated.
Additional Manufacturer Narrative
Context: ********** a customer in portugal reported to biomérieux a potential misidentification as brucella spp in association with the product vitek ms instrument (ref.(b)(4), serial number (b)(6)) with a sample.Vitek ms mode : ivd kb version : 3.2 (ind) issue type : doubtful brucella spp identification for a rod-shaped gram positive microorganism vitek ms results : -first tests = one low discrimination to bacillus cereus group - brucella melitensis and two no identification (one spot acquired three times) -second tests = one single choice to brucella melitensis -third tests = three no identification (one spot acquired three times) other methods : unknown expected id: unknown, no reference method performed culture conditions: -origin : unknown -culture media : tsa plate -incubation: 48h, 30-35ºc -spotting tool : vitek pickme issue date: (b)(6) 2023 fine tuning date before the issue: (b)(6) 2023 investigation: **************** 1.Complaint trend analysis and device history record there is no out-of-control alert, or a non-confirmed out-of-control alert in cstat for the period from (b)(6) 2023 for the error code ivd mis-identification - f871.2.Investigation results fine tuning according to the vilink alert tool criteria, no fine tuning was needed during the tests made on (b)(6) 2023 note : good fine tuning and good calibrator spot preparation are a prerequisite for monitoring the system with vilink alert tool spot preparation quality the calibrator and the sample ¿all peaks¿ values are quite heterogeneous.Based on this finding, the spot preparation quality needs to be verified with the customer kb review unknown, no reference method has been performed sample data analysis reprocessing the customer¿s data with vitek ms kb v3.2 allows to show that the misidentification to brucella spp was obtained from spectra having a low number of peaks (38 and 40) and with negative score.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).Reprocessing the customer¿s data with vitek ms kb v3.3 show that this new vitek ms knowledge base allows to eliminate the misidentification to brucella spp.All tests led to no identification results, it could be a species out of the knowledge bases.Based on this analysis, the issue is probably link to a non-optimal sample spot preparation and a kb weakness linked with the bad quality of spectra.In addition, it could also be combined with a system limitation (species not present in the vitek ms knowledge bases) for information, the following limitations are written in the user manual supplements - 161150-923 - a - en - vitek ms industry use - v3.2 knowledge base : * 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.* 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.¿ based on the complaint description, this customer has updated his system to vitek ms kb v3.3.It will allow to eliminate this kind of issue.Expected identification after investigation unknown, no reference method performed 3.Root cause analysis -non optimal spot preparation -system limitation 4.Corrective or preventive actions no capa number is needed.Conclusion: ************** the issue has not been reproduced internally and no malfunction has been identified.Some recommandations have been made to assist the customer: - check sample preparation with the customer.Provide the ¿customer training materials¿ to help him to improve his spot preparation technique (video, training, ¿ ).- propose to use vitek pickme for both calibrator and sample preparation in order to improve the spot quality.- organize a ¿spot quality assessment spotting challenge test¿, documents explaining you how to do it are attached to the case (zip file).These kind of tests are made during vitek ms training in order to visualize and understand the impact of the spotting quality on vitek ms performances.

• Brand Name: VITEK® MS
• Common Device Name: 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: 18039157
• Report Number: 9615754-2023-00045
• Device Sequence Number: 20932238
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K181412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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 Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown