MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK® MS INSTRUMENT

Model Number 423118

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a brucella spp.Misidentification result in association with the vitek® ms rp5810 acq pc kit v3 win10 (ref.423118, serial (b)(4)) when testing a patient isolate.The customer confirmed the isolate was cultured on campylobacter agar and obtained an identification of brucella spp.With a confidence level of 99.9%.The isolate was also tested using the pcr and agglutination test methods.The customer confirmed the agglutination test was negative; the pcr result has been requested but not provided.There is no adverse patient impact.The customer confirmed that there was no incorrect or delayed patient treatment caused by the brucella spp misidentification result.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer in the belgium notified biomérieux of obtaining a brucella spp.Misidentification result in association with the vitek® ms rp5810 acq pc kit v3 win10 (ref.(b)(4), serial (b)(6)) when testing a patient isolate.Investigation: the investigator reviewed the device history record.No capas nor non-conformities for vitek® ms instrument can be linked to this customer¿s report.Fine tuning (ft): status good at the time of acquisition and according to the vilink alert tool criteria, no fine tuning was needed during the tests made on (b)(6) 2021.Indeed, the ft is not questioned because it was performed just before the issue and met all necessary criteria.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review: based on the information provided by the customer, the suspected identification seems to be a campylobacter strain.However, the identification remains unknown as no reference method was used to confirm the id.Sample data analysis: the potential misidentification as brucella spp was obtained from the spectra having a low number of peaks which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (30).The quality of spectra seems to be not optimal.Reprocessing the submitted customer data with the newest version of the vitek ms kb under development led to identification as campylobacter; the result is in alignment with the selective media used (campylobacter agar).The cause of the misidentification as brucella spp is a kb weakness with a bad quality of spectra (linked to a non-optimal spot preparation).Significant improvements have been made by r&d for next vitek ms kb version to limit misidentification to brucella spp.In addition, vitek® pickme could be used to optimize the quality of deposit.A sequencing of the strain is needed to confirm the strain identification.The strain seems to be a species out of vitek ms knowledge base.The following system limitation is mentioned in the vitek ms 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: per the investigation, this customer¿s issue appears to be due to non-optimal spot preparation.A system limitation exists regarding how the instrument handles the spectra for species which are not included in the knowledge base library.An identification confirmation via a reference method (i.E.Genetic sequencing) should be performed in cases where the identification provided by the vitek® ms instrument is suspect or inconclusive.Local customer service provided additional training materials to the customer to help improve the spot preparation technique.Customer service also provided information regarding vitek® pickme¿ (ref (b)(4)) to help with sample spot preparation.

• 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 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12955306
• MDR Text Key: 287918938
• Report Number: 9615754-2021-00291
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 01/07/2022

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 Model Number: 423118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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