MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS

Model Number 410895

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported a misidentification of candida dubliniensis in association with the vitek® ms instrument.The customer reported that testing from a blood plate gave an identification of candida dubliniensis, and a chromid plate result was candida albicans.The customer stated that no incorrect result was reported and that patient results and treatment were not impacted.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in israel regarding a misidentification of candida dubliniensis in association with the vitek® ms instrument.The customer reported that testing from a blood plate gave an identification of candida dubliniensis, and a chromid plate result was candida albicans.A biomérieux internal investigation was completed.Complaint trend analysis and device history record: trend analysis was completed regarding the complaints recorded for a misidentification due to the "use of a non-compatible culture media with vitek ms".Since (b)(6) 2016, no similar complaint has been recorded for any isolate of c.Dubliniensis misidentified as c.Albicans.Review of the device history record did not highlight any issue during manufacturing for this lot number (reference).Conclusion on the system: the fine tuning analyzer report from the last fine tuning done before the identifications issues was not provided.It was not possible to verify if all the mandatory fine tuning criteria were met.Conclusion on the spot preparation quality: the customer's spot preparation quality was not optimal.The calibrator and sample "all peaks" values were very heterogeneous.This could be explained by a non-optimal spot preparation (culture, spot, different operator).Spot preparation needs to be verified with the customer.Conclusion on the identification: based on the complaint description the expected identification is candida dubliniensis.The dendrogram made with customer spectra showed that the spectra acquired from blood plate and from chromogenic plates were totally different, they formed two different clusters.Moreover, there was a lower number of peaks for tests made with local chromogenic plates.The customer spectra analysis showed that the proteins were not expressed in the same way on the two culture media used, peak lists were very different.The local chromogenic culture media seemed to be not compatible with vitek® ms.The customer has to use the blood agar culture media instead of the local chromogenic culture media.In the vitek® ms workflow user manual 4501-2233, the following instructions are written : "appropriate media, including commercial media (such as columbia blood agar), most frequently used in clinical microbiology laboratories, should be used.Note: a certificate of compatibility listing the validated media can be downloaded from the biomérieux technical library." suspected cause retained.Use of a non-compatible culture media with vitek® ms.

• 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: 8800713
• MDR Text Key: 152105765
• Report Number: 9615754-2019-00049
• Device Sequence Number: 1
• Product Code: PEX
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: DEN130013
• 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: 04/01/2020

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: 06/21/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1