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 from (b)(6) notified biomérieux of the misidentification of staphylococcus aureus as staphylococcus warneri when testing with the vitek® ms instrument (ref.410895).The customer reported that there was no patient harmed or treated incorrectly due to the discrepant result.The customer stated there was no delay in reporting results.A biomérieux internal investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification by a customer in saudi arabia regarding the misidentification of staphylococcus aureus as staphylococcus warneri when testing with the vitek® ms instrument (ref: (b)(4).The identification to staphylococcus aureus was obtained via bd phoenix system.Biomérieux investigation was conducted.Test data from the customer's vitek ms system was analyzed: the vitek ms system was not performing optimally during the tests.A fine-tuning procedure is required to return the system to expected performance levels.The customer's spot preparation technique/quality was not optimal.The calibrator "all peaks" values are heterogeneous.This could be explained by a non-optimal spot preparation (culture, spot, different operator, etc.).The strain submitted by the customer was tested internally (five spots) with vitek ms kb v3.2 and all the spots gave a single choice to macrococcus caseolyticus.The isolate was sent for 16s sequencing, returning the final identification of macrococcus caseolyticus.The reported organism identification issue was not reproduced internally.Vitek ms provided the expected identification.Root cause of the customer's reported issue: the need for fine-tuning.Non-optimal spot preparation by the customer.Based on complaint record review from january 2016, no other similar identification issue has been recorded: staphylococcus warneri instead of macrococcus caseolyticus and/or staphylococcus warneri instead of staphylococcus aureus.

• Brand Name: VITEK® MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 8727589
• MDR Text Key: 211137473
• Report Number: 9615754-2019-00046
• 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: 12/03/2019

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: 05/29/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1