MAUDE Adverse Event Report: BIOMERIEUX, 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

A customer in (b)(6) notified biomrieux of obtaining a misidentification of eikenella corrodens while testing three (3) sets of pleuritic fluid specimen, from the same patient and collected at the same time, with the vitek ms instrument reference # 410895, serial #(b)(4).0ayqmbr - sample from culture plate.Vitek ms - 24 hours incubation - kingella denitrificans.Vitek ms - 48 hours incubation - kingella denitrificans.0ayqmbc - sample from culture plate.Vitek ms - 24 hours incubation - no identification.Vitek ms - 48 hours incubation - kingella denitrificans.Vitek 2- 48 hours incubation - eikenella corrodens.Sequencing incubation - eikenella corrodens.0ayqtfl - sample from positive bact/alert bottle, inoculated to culture plate after flagging positive the day after collection.Vitek ms - 24 hours incubation - no identification.Vitek ms - 48 hours incubation - three (3) single choice to enterococcus faecium.Vitek 2- 48 hours incubation - eikenella corrodens.Sequencing incubation - eikenella corrodens.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomrieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in taiwan regarding a misidentification of eikenella corrodens while testing three (3) sets of pleuritic fluid specimen, from the same patient and collected at the same time, with the vitek® ms instrument (reference # 410895, serial # (b)(6)).A biomérieux internal investigation has been completed with the following results: -review of fine tuning indicated no fine tuning was needed during the tests made between 14nov2020 and 15nov2020.-the customer's spot preparation quality was not optimal.The calibrator and sample "all peaks" values were quite heterogeneous.-the expected identification is eikenella corrodens (for the 3 samples) which is present in the vitek ms v3.2.-the sample data was analyzed with the following results: ->reprocessing the customer data with vitek ms kb v3.2 for sample 0aymqmbc resulted in two no identification results at 24 hours and one single choice to kingella denitrificans.The misidentification shows that there is an heterogeneous number of peaks, it varies between 85 and 158.This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator).-> for 0ayqmbr also there was a heterogeneous number of peaks, it varies between 71 and 116.This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator).->for 0ayqtfl, the identifications were discrepant.The customer has to confirm the strain identification with reference method (sequencing).Sequencing was done and confirmed eikenella corrodens.Based on these findings, the probable cause of the misidentification could be linked to a non-optimal spot preparation.However, further investigation is not possible as the customer no longer has the strains.Consequently, the cause of the issue was determined as unknown.

• Brand Name: VITEK MS INSTRUMENT
• 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: 11197384
• MDR Text Key: 243139497
• Report Number: 9615754-2021-00009
• 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: 02/23/2021

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: 12/20/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1