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 Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

An investigation has been performed by analyzing the customer¿s data.Fine tuning: according to the complaint, a fine tuning was performed (b)(6) 2020 just before testing was performed and it conformed to specifications.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values are quite heterogeneous.In case of optimal spot preparation, the ¿all peaks¿ values of calibrators spectra should be homogeneous.Knowledge base (kb) review: the expected identification is pseudomonas monteilii, which is present in the vitek ms knowledge base (b)(4).Sample data analysis: reprocessing of the customer data with vitek ms kb (b)(4) showed that there is a heterogeneity of the ¿all peaks¿ number; it varied between 67 to 117.However, it seemed to not be the cause of the issue as all tests gave the same misidentification to pseudomonas putida.Reprocessing of the customer data with new vitek ms kb (b)(4) in development obtains the same results as vitek ms kb (b)(4).No improvement observed.Reprocessing of the customer data with saramis (b)(4) (ruo mode) demonstrated : the spectra acquired seems to be closed to pseudomonas putida.It is difficult to separate this strain of pseudomonas monteilii from other pseudomonas species.Pseudomonas monteilii dsm 14164 has not been tested during our knowledge base development.The pseudomonas monteilii class was built with 8 spectra / 3 strains.This is lower than for pseudomonas putida (58 spectra - 27 strains).It could explain the results observed by the customer.Biomérieux assessed the risk associated with this issue and determined that the overall risk is irrelevant.A change request was opened by r&d to improve these two classes with new spectra acquisitions in order to increase the discriminant power of the kb for these species.Additionally.It was recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique.

Event Description

A customer in the united states notified biomérieux of a misidentification of an atcc® pseudomonas monteilii strain as pseudomonas putida species in association with the vitek® ms instrument ¿ (ref.410895), serial number: (b)(4).The customer stated that the pseudomonas monteilii was a quality control strain from an atcc® source.They obtained an identification as pseudomonas putida (with 99.9% of confidence), twice.They assert the spot quality was good and 1ul was added.The customer is an industry facility and the strain tested is a quality control sample, thus no patient was involved.

• 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: jennifer schmatz ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 10992717
• MDR Text Key: 241368494
• Report Number: 9615754-2020-00191
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2020

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: 11/11/2020
• Initial Date FDA Received: 12/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1