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

Model Number 410895

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomerieux of obtaining a misidentification of spingomonas paucimobilis as brucella spp.When using the vitek® ms instrument (ref.410895, serial (b)(4).The customer stated that they had tested an isolated colony from a patient¿s sample for identification testing using vitek ms, and they obtained an identification of brucella.The customer stated that the brucella identification result was not consistent with other routine manual tests like gram staining, urease or modified staining.The customer tested a suspension of the microorganism with the vitek® 2 gn id card and obtained an identification of spingomonas paucimobilis with 93% probability.Retesting the patient isolate with vitek ms gave "no result".The customer stated that brucella result was not reported to the physician.There is no indication or report from the customer to biomérieux that the reported issue led to any adverse event related to the patient's state of health.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

A customer in india notified biomérieux of obtaining an incorrect organism identification result in association with their vitek® ms instrument (ref.(b)(4); serial# (b)(6)).Their vitek misidentified the organism as brucella spp, however the gram stain and urease results were not consistent with a brucella identification.Vitek 2 testing suggests the sample is shingomonas paucimobilis, but actual organism identity is unknown as no reference method (i.E.Sequencing) was performed to confirm.Investigation: fine-tuning: the analyzer report for the fine-tuning performed before the identification issue was not provided, thus the investigator cannot draw any conclusions regarding the fine-tuning status at the time of the misidentification.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Optimal preparation should yield homogeneous values.Knowledge base (kb) review: the expected identification remains unknown as it was not confirmed using a reference method.Based on the gram stain, urease, and vitek 2 tests, results suggest the sample is s.Paucimobilis, which is present in the customer¿s knowledge base version (v3.2).Sample data analysis: the analysis of the mzml samples files show the identification was obtained from spectra having a low number of peaks (44) which is near but above the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result.Reprocessing the customer data with the knowledge base version under development, lead to a ¿no identification¿ result.Root cause was determined to be non-optimal spot preparation by the user, in addition to how the customer¿s knowledge base handles less-than-optimal spectra.A change request has been submitted for the next vitek ms kb version - to limit misidentification of brucella spp.It was also recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique, and review with them the procedure for fine-tuning.

• 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
• MDR Report Key: 11181384
• MDR Text Key: 238599827
• Report Number: 9615754-2021-00008
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

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: 410895
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 01/19/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1