MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS; VITEK® MS

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 customer in (b)(6) notified biomérieux of a misidentification of aeromonas hydrophila as aeromonas media while testing a ukneqas survey sample with the vitek® ms (ref 410895, serial (b)(4)).The specimen tested was the ukneqas distribution 4683, specimen 5732.The customer reported obtaining a single choice identification of aeromonas media three (3) times when testing isolates cultured on three (3) different media types.Additionally, a low discrimination identification of aeromonas media / aeromonas salmonicida/bestarium was obtained when the organism was cultured on a fourth media type (media type unknown).Vitek ms from mueller hinton: aeromonas media.Vitek ms from mckonkey: aeromonas media.Vitek ms from yersinia plate: aeromonas media.Vitek ms from unknown: low discrimination - aeromonas media / aeromonas salmonicida/bestarium.Expected: aermonas hydrophila.As this was a ukneqas survey sample, there is no patient involved.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in switzerland regarding a misidentification of aeromonas hydrophila as aeromonas media while testing a ukneqas survey sample with the vitek® ms (ref 410895, serial (b)(6) the specimen tested was the ukneqas distribution 4683, specimen 5732.The fine-tuning report was not provided by the customer; therefore, the status of the vitek® ms system could not be analyzed.Analysis of the mzml sample results showed the number of all peaks are very low and heterogeneous during the issue.Moreover, the misidentification results were obtained from the spectra having a lower number of peaks (39 and 41) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (30 peaks).This could be explained by a non-optimal spot preparation of the sample strain.This would need to be verified with the customer.The customer¿s strain was not returned for the investigation because biomérieux¿s r&d department already had the strain.Biomerieux has subscribed to the external quality control - neqas 4683 ¿ sample n° 5732.The sample was sent directly by neqas.The qc lab tested five (5) spots on vitek® ms v3 and obtained four (4) single choice to aeromonas media, and one (1) low discrimination to aeromonas media - aeromonas salmonicida/bestiarum.The lab did not obtain the expected identification to aeromonas hydrophila.Biomérieux r&d investigations identified the customer strain to aeromonas media by gyrb-aero gene sequencing.The sequencing result is in accordance with biomérieux qc lab and the customer¿s vitek® ms results.There was no misidentification issue with vitek® ms (ref 410895, serial (b)(6)).Vitek® ms provided the expected identification, there was no malfunction.

• Brand Name: VITEK MS
• Type of Device: VITEK® MS
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 10693714
• MDR Text Key: 241258969
• Report Number: 9615754-2020-00162
• 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: 04/07/2021

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: 09/21/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1