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

An internal complaint was initiated following a review of a scientific publication entitled, "high rates of misidentification of uncommon candida species causing bloodstream infections using conventional phenotypic methods" by huang y.Et.Al.This scientific publication presents a retrospective study of the identification of uncommon candida species causing bloodstream infection by conventional methods (api-32c and vitek®2, yeast id), vitek ms (reference # 410895), and its sequencing.The direct impact of a candida species' misidentification on patient care, and the outcome was not addressed in the publication.All the candida species isolates studied were recovered from bloodstream infections and thus would have had susceptibility performed on each of the isolates, minimizing the impact of a misidentification.Respect for the instructions for the use of the product: the api®-32c, vitek®2 yeast id, and the vitek® ms identification system were used per the manufacturer's intended use.The authors do not describe how they set up the api®-32c and vitek®2 yeast id systems but describe how they set up the yeast on the vitek® ms, following manufacturer instructions.The relevance of the methodology: the methodology used in the study was relevant.The authors wanted to assess the capability and accuracy of different identification systems at correctly identifying uncommon candida species.The vitek ms version 3.0.Was used for the analysis of the spectra.The authors followed the following criteria "all identifications displaying a single result with a confidence value of 99.9% were considered acceptable" for acceptable id.The authors used the its sequencing identification as the true id.Observed study results: the accuracy of identification of these uncommon candida species by conventional methods (api-32c and vitek®2 yeast id) was 64.3% (54/84), and the rate of correct identification of these isolates by vitek ms was 86.9% (73/84).The study tested 85 isolates using the vitek ms.One of the isolates was not included in the summary as no confirmed identity was obtained.Therefore, the final results include only 84 isolates.The vitek® ms misidentified: one (1) c.Palmioleophila as c.Guilliermondii.Two (2) c.Guilliermondii as c.Parapsilosis.One (1) c.Metapsilosis as c.Guilliermondii.One (1) c.Pelliculosa as c.Guilliermondii.One (1) magnusiomyces capitatus as saprochaete capitat.Six (6) isolates gave a no identification result; therefore, these were not considered misidentifications.Note, as per vitek ms clinical user manual: "testing of species not found in the database may result in an unidentified result or a misidentification.¿ there is no indication or report in the publication that any results obtained in this study were used for diagnosis and/or treatment decisions.In addition, the publication does not list the number of patients involved with the isolates.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from an internal complaint from biomérieux china regarding review of a scientific publication entitled, "high rates of misidentification of uncommon candida species causing bloodstream infections using conventional phenotypic methods¿.The authors wanted to assess the capability and accuracy of different identification systems at correctly identifying uncommon candida species.The vitek ms® version 3.0.0 was used for the analysis of the spectra.Expert evaluations of the publication were performed for the investigation by research & development (r&d) and global medical affairs (gma) personnel.The evaluations were performed per biomérieux¿s global procedure for monitoring of scientific publications as part of the post market surveillance (pms) and vigilance processes.Both expert evaluations concluded that no further investigation was needed for this event.Based on the investigation results, there is no identification issue with vitek ms.There was no major concern with the performance of vitek® ms.

• 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: 11166893
• MDR Text Key: 255898797
• Report Number: 9615754-2021-00006
• 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,l
• 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: 12/14/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1