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

Catalog Number 410895

Device Problem Incorrect Measurement (1383)

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 hong kong notified biomérieux of obtaining a misidentification of a blood culture specimen as brucella spp when using the vitek ms - reference (b)(4) ( serial number : (b)(6).Indeed, vitek ms result brucella spp.Does not match gram-stain result.Customer obtained a positive blood culture specimen, and subcultured it on horse blood agar, incubated at 35 degree celsius with 5% co2 for 48 hours.The colony was pure.The growth was poor, as described by customer.Summary vitek ms results not enough peak, not enough peak, brucella spp.¿ 98.8%, brucella spp.¿ 99.9%, not enough peak, no identification additional testing gram stain: gram positive, rod, beaded, sanger sequencing ¿ mycobacterium species.The customer indicates the reporting result has been delayed by 4 hours.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.Severe injury results from an incorrect organism identification.Lack of appropriate diagnosis or therapy, continued administration of inappropriate antimicrobials or other potentially toxic therapies may result.Illness or injury depends on pathogenicity of the organism and host immune status.Highly pathogenic organisms are more likely to cause harm.Other tests and patient symptoms are considered in making a diagnosis.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 hong kong notified biomérieux of obtaining a misidentification of a blood culture specimen as brucella spp when using the vitek ms - reference (b)(4) (serial number : (b)(6).Indeed, vitek ms result brucella spp.Does not match gram-stain result.Customer obtained a positive blood culture specimen, and subcultured it on horse blood agar, incubated at 35 degree celsius with 5% co2 for 48 hours.The colony was pure.The growth was poor, as described by customer.Investigation results.Fine tuning.Good fine tuning and good calibrator spot preparation are a prerequisite for monitoring the system with vilink alert tool.According to the vilink alert tool criteria, no fine tuning was needed during the tests made spot preparation quality.The calibrator and the sample ¿all peaks¿ values are quite heterogeneous.The ¿sample all peaks¿ varies between 13 to 35; it could be due to the fact that the growth was poor.Knowledge base review.Mycobacterium spp is not present in vitek ms knowledges bases.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 (35) and with low scores.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 of the data with saramis reference spectra allows to obtain no identification for all spectra.Based on this analysis, the misidentification is linked to a knowledge base weakness in case of bad quality of spectra (non optimal sample preparation).In addition, it could also be combined with a system limitation (species not present in the vitek ms knowledge bases).Limitations on the user manual.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.¿ 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 is fixed with the vitek ms kb v3.3.Expected identification after investigation.Unknown.Conclusion.The investigation indicates that the suspected causes retained are a non optimal spot preparation and a system limitation.

• Brand Name: VITEK MS INSTRUMENT® - 410895
• Type of Device: VITEK MS INSTRUMENT® - 410895
• 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: 18225866
• MDR Text Key: 329202888
• Report Number: 9615754-2023-00052
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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: 12/13/2023

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 Operator: Health Professional
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1