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 (b)(6) notified biomérieux of the misidentification of a patient staphylococcus argenteus isolate as staphylococcus aureus in association with the vitek® ms instrument (ref.410895, serial (b)(4)) with knowledge base (kb) v3.2.The customer stated the vitek® ms instrument identified the patient isolate as staphylococcus aureus, the lab concluded that it was a mrsa (testing technique was not provided).The customer confirmed the result of (b)(6) was reported to the treating physician.The sample was then sent to reference laboratory, and tested using bruker maldi tof, which identified the isolate as staphylococcus argenteus.The customer confirmed the misidentification had no adverse impact to the patient¿s state of health.Note: staphylococcus argenteus is not included in the knowledge base (kb) v3.2.The vitek® ms user manual, paragraph limitations: testing of non-clinically validated species of species not found in the database may result in an unidentified result or misidentification".Biomérieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in sweden regarding the misidentification of a patient staphylococcus argenteus isolate as staphylococcus aureus in association with the vitek® ms instrument (ref.(b)(4) serial number (b)(4)) with knowledge base (kb) v3.2.A biomerieux investigation was performed using the data submitted by the customer.*conclusion on the fine tuning: the fine tuning performed before the misidentification issue was conforming.All the mandatory fine tuning criteria were achieved.The analysis of the calibrator mzml files indicated no fine tuning was needed during the test made on 16-jan-2020.*conclusion on spot preparation quality: the analysis of the calibrator mzml show that the spot preparation quality was heterogeneous.The spot preparation quality has to be verified with the customer.*conclusion on the identification: staphylococcus argenteus is not present in the vitek ms kb v3.2.There is a system limitation mentioned in the vitek ms knowledge base user manual ref.161150-924 a for vitek ms clinical use v3.2 which states: ¿* testing of species not found in the database may result in an unidentified result or a misidentification.¿ *root cause analysis: system limitation: staphylococcus argenteus is not present in the vitek ms kb v3.2.

• 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: 9820048
• MDR Text Key: 206148863
• Report Number: 9615754-2020-00039
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• 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: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1