MAUDE Adverse Event Report: BIOMERIEUX, SA 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

A customer in the united states notified biomérieux of obtaining misidentification results when performing validation testing with the vitek® ms instrument (ref 410895).The customer had an instrument replacement.They performed validation testing on the new instrument with four patient samples that had previously identified as enterobacter cloacae/asburiae (50/50 split as expected) on their previous vitek ms instrument.Each isolate was identified as enterobacter hormaechei consistently with the new instrument.The customer was confirmed to be on knowledge base (kb) version 3 both prior to the new instrument installation and with the current instrument.These patient results were previously reported at the species level.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.The instrument was not in biomérieux's validation step.The instrument has been released to the customer, and it was considered operational.The customer was performing their own validation with their own samples.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding misidentification results when performing validation testing with the vitek® ms instrument (b)(4).The customer had an instrument replacement.They performed validation testing on the new instrument with four patient samples that had previously identified as enterobacter cloacae/asburiae (50/50 split) on their previous vitek ms instrument.Biomérieux investigation was conducted.Based on the customer information, the expected identification is the result obtained with the original vitek ms (i.E.Low discrimination to enterobacter cloacae / enterobacter asburiae).No further information has been received regarding any other testing methods used by the customer to confirm an organism identification.Evaluation of the submitted test data showed that the vitek ms systems (both the original unit and the new unit) were operational.In addition, the customer's spot preparation quality seemed to be homogeneous.This could be extrapolated to the sample preparation quality.The test data was re-processed using vitek ms kb v3.3 (under development); all spectra except one led to the same identification result (enterobacter hormaechei spp hoffmannii).With kb 3.3, modifications were made for the identification of enterobacter species.Strains have been re-classified with more accurate sequencing methods (gyrb).The investigation concluded the root cause as the vitek ms kb v3.2 knowledge base capabilities related to this specific organism identification of enterobacter cloacae.

• 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: 8524809
• MDR Text Key: 152099782
• Report Number: 9615754-2019-00023
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• 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: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1