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

Catalog Number	410895
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Intended use: the vitek® ms system is a mass spectrometer using maldi-tof (matrix-assisted laser desorption/ionization-time of flight) technology for the identification of microorganisms cultured from clinical specimens.Description of the issue: a customer in hong kong notified biomerieux of obtaining a misidentification of a staphylococcus aureus as brucella spp when testing a blood culture specimen with the vitek ms serial# (b)(6).Indeed, upon identification by vitek ms, brucella spp.Was reported with 99.9%.Customer repeated testing by re-spotting, and obtained a result of s.Aureus with 99.9%.Gram stain suggested that s.Aureus should be the correct result as gram stain revealed that the specimen is gram + coccus.Summary: blood culture specimen.Initial testing - vitek ms.Brucella sp.Repeat testing - vitek ms.Staphylococcus aureus.At the time of the assessment, there is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
Context.A customer in hong kong notified biomerieux of obtaining a misidentification of a staphylococcus aureus as brucella spp when testing a blood culture specimen with the vitek ms (serial# (b)(6).Investigation results.Fine tuning.A fine tuning was needed at the time of acquisition.However, as several mandatory information are not achieved from the fine tuning report made before the identification issue, it was not possible to define if it was conform.Based on this finding, the fine tuning status analysis could be not relevant because these criteria are a prerequisite for monitoring the system with vilink alert tool.Spot preparation quality.The customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Knowledge base review.The expected identification is unknown because no reference method was used to confirm the expected identification.Sample data analysis.Analyze of mzml sample files shows that the spectra which gave the misidentification to brucella spp have the lowest number of peaks (54 peaks).Moreover, this misidentification was obtained with a low identification score (-0.18) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator).By reprocessing the customer data with next vitek ms kb v3.3, spectra which gave misidentification results as brucella spp led to no identification.There is no more misidentification.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 was fixed with the new vitek ms kb v3.3.Conclusion.The suspected cause retained following the investigation are a non optimal spot preparation, the knowledge base weakness linked with the bad quality of spectra and fine tuning needed at the time of the acquisition.

• Brand Name: VITEK MS INSTRUMENT®
• Common Device Name: VITEK MS INSTRUMENT®
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: pauline prévitali ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17430068
• Report Number: 9615754-2023-00038
• Device Sequence Number: 7153050
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 08/28/2023

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
• Operator of Device: Health Professional
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/28/2023
• Is the Device Labeled for Single Use? (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