MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS PRIME - 423281

Catalog Number 423281

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use the vitek® ms systems 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 belgium notifed biomérieux of obtaining a misidentification of an unknown strain as brucella species when using the vitek ms prime - 423281( serial number : (b)(6) ) summary 2 samples initial testing - vitek ms identification brucella 99% alternate method testing - pcr pcr negative.For now, the expected identification is unknown.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.This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting.Biomérieux internal standard operational procedures states that erroneous test results could result in a lack of appropriate diagnosis or therapy, continued administration of inappropriate antimicrobials, or other potentially toxic therapies.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context.A customer in belgium notifed biomérieux of obtaining a misidentification of an unknown strain as brucella species when using the vitek ms prime - 423281( serial number : (b)(6).Investigation results.Complaint analysis.The analysis does not indicate any systematic quality issue.Fine tuning.Status low.The fine tuning is due.Spot preparation quality.The customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.Knowledge base review.The expected identification is unknown because no reference method was used.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 (43 peaks).Moreover, this misidentification was obtained with a low identification score (-0.01) 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.With an internal research database, we obtained weeksella massiliensis.The customer has to confirm the strain identification by a referent method.The customer strain could be a species out of the vitek ms knowledge base.The following system limitation is mentioned in the vitek ms prime clinical use - v3.2 knowledge base - user manual ref.(b)(4): ¿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.¿ conclusion.Investigation conclusion could be done without any strain submittal.The investigation indicates that the misidentification could have been caused by a lack of fine tuning monitoring, a knowledge base weakness linked with the bad quality of spectra and/or a non optimal spot preparation.It has been recommended to check sample preparation with the customer to help him to improve his spot preparation technique (video, training.).

• Brand Name: VITEK MS PRIME - 423281
• Type of Device: VITEK MS PRIME - 423281
• 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: 18835313
• MDR Text Key: 337784451
• Report Number: 9615754-2024-00009
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K212461
• 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: 04/15/2024

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 Catalogue Number: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1