MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT - 410895; VITEK® MS INSTRUMENT - 410895

Model Number 410895

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A client from united states reported to biomérieux that they obtained an organism misidentification.A patient sample, used for research purposes, was analyzed using vitek® ms (s/n: (b)(4)) and gave a result of bifidobacterium spp.Instead of the expected identification to escherichia coli.The sample was processed again on vitek ms, as well as the bruker ms instrument.The results were in line with what was expected: escherichia coli.The vitek ms mzml data files were not available for evaluation.As the tested sample was being used for research, there was no treatment/therapy prescribed to any patient based on the discrepant result.

Manufacturer Narrative

A customer in the united states notified biomérieux of obtaining the misidentification of escherichia coli as bifidobacterium spp.In association with their vitek® ms instrument (ref.(b)(4); serial# (b)(6)).The strain identification was confirmed as e.Coli by reprocessing the strain on vitek ms and bruker ms.Investigation: investigator reviewed the complaint database for additional reports reflecting the customer's issue.There is no capa, no non-conformity on vitek ms linked with customer 's complaint.Since (b)(6) 2016, there have not been any reports of misidentifying e.Coli as a bifidobacterium spp.Fine-tuning: according to the vilink alert tool criteria, no fine-tuning was needed during the tests made on (b)(6) 2020.Spot preparation quality: based on the data logs submitted from the customer site, the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review: the expected identification is e.Coli which is present in the vitek ms knowledge base v3.2 (the customer¿s version).Sample data analysis: the analysis of the mzml files show the spectra have a low number of peaks (38 and 49) which is just above the acceptable limit (30) for giving an ¿identification¿ result or a ¿no identification¿ result.In addition, the identification was obtained with a low identification score (-0.25 and -0.27) which is also near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).Root cause was determined to be non-optimal spot preparation by the user.It was recommended that local customer service check sample preparation with the customer and provide customer training materials to improve their spot preparation technique, as well as reviewing with them the procedure for fine-tuning.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK® MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11139043
• MDR Text Key: 225756672
• Report Number: 9615754-2021-00002
• 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: health professional,user faci
• 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: 12/09/2020
• Initial Date FDA Received: 01/08/2021
• 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