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

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

An internal complaint was initiated following a review of a scientific publication entitled, "comparative evaluation of the bruker biotyper and vitek ms matrix-assisted laser desorption ionization-time of flight (maldi-tof) mass spectrometry systems for non-albicans candida and uncommon yeast isolates" by teke l., et al.The publication noted one (1) misidentification of meyerozyma caribbica as candida guilliermondii in association with the vitek® ms (ref# 410895, serial#(b)(4)).They were using knowledge base (kb) version (b)(4).The publication was written about a comparison study between bruker maldi biotyper, vitek ms, and bd phoenix for 157 isolates representing 23 yeast species (of 15 non-albicans).An isolate was considered correctly identified if two maldi-tof ms systems yielded the same results.Its sequencing was performed on all isolates with disagreeing identification results between the two maldi-tof ms systems.In addition, isolates with disagreeing or no identification results were tested with vitek ms saramis.The publication noted that the bruker ms was using a threshold >= 1.7 instead of the recommended threshold of 2.This caused them to have more species identifications.Two maldi-tof ms systems gave 152 agreeing results and five discrepant results which were further clarified by its sequencing and vitek ms saramis database.Its sequencing revealed that vitek ms ivd misidentified one meyerozyma caribbica isolate as candida guilliermondii.The other four isolates were appropriately not identified by the vitek ms because the isolate was not in the knowledge base.As the isolate was tested as part of a scientific study, there was no patient directly associated with the testing result.Therefore, there was no adverse impact to any patient's state of health as a result of the testing.

Manufacturer Narrative

This report was initially submitted following review of a scientific publication entitled, "comparative evaluation of the bruker biotyper and vitek ms matrix-assisted laser desorption ionization-time of flight (maldi-tof) mass spectrometry systems for non-albicans candida and uncommon yeast isolates" by teke l., et al.The publication noted one (1) misidentification of meyerozyma caribbica as candida guilliermondii in association with the vitek® ms (ref# 410895, serial#(b)(6)).They were using knowledge base (kb) version 3.2.A biomérieux internal investigation has been completed with the following results: complaint trend analysis and device history record: a trend analysis was completed regarding the complaints recorded for a misidentification due to a non optimal spot preparation and a non optimal fine tuning.Probability as per safety risk management procedure 001622 rev 06.A: improbable.Since january 2016, no similar complaint has been recorded, from a different customer.No isolate of meyerozyma caribbica (candida fermentati) misidentified as candida guilliermondii.There is no capa, no non conformity on vitek® ms linked with customer 's complaint.Conclusion on the fine tuning: the fine tuning done before the identification issue was not conform.Several mandatory criteria were not met.Conclusion on spot preparation quality: the customer's spot preparation quality was not optimal.The calibrator and sample "all peaks" values were heterogeneous.This could be explained by a non-optimal spot preparation (culture, spot, different operator).Conclusion on the identification: according to customer's information, the expected identifications was: meyerozyma caribbica (candida fermentati).The suspected identification, candida fermentati, was present in vitek ms kb v3.2.Considering all the information provided, the misidentification was due to bad spectra quality (spectra with a low amount of peaks).This could be explained by a non-optimal spot preparation of the samples strains (culture, spot, different operator).Root cause analysis: non optimal spot preparation.Non optimal fine tuning.

• Brand Name: VITEK® MS
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, les grottes isere 38390 ; FR 38390
• MDR Report Key: 9644624
• MDR Text Key: 206147600
• Report Number: 9615754-2020-00025
• 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,l
• Type of Report: Initial,Followup
• Report Date: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• 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
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1