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

A customer from (b)(6) notified biomérieux of a misidentification of cutibacterium acnes while using the vitek® ms instrument (ref.410895, serial number (b)(4)).The customer had both an aerobic and anaerobic blood culture bottle of the same patient sample.Both blood culture bottles were tested on the vitek® ms instrument after sub-culturing on agar plates.The vitek ms instrument obtained an identification of cutibacterium acnes for the aerobic culture and vibrio fluvialis or vibrio fluvialis/ e.Faecalis for the anaerobic culture.Microscopic examination showed an identification of cutibacterium acnes for both cultures.Due to the discrepant result, the customer repeated the testing on the anaerobic culture on the same day.Again an identification result of vibrio fluvialis was obtained.On (b)(6) 2019, both blood culture isolates were tested again, and the vitek® ms instrument gave identification results of cutibacterium acnes for both bottles.Based on microscopic examination and the vitek® ms result, the identification of cutibacterium acnes was reported, and patient treatment was not affected.There was no adverse event related to the patient's state of health as a result of this misidentification.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted when a customer from germany notified biomérieux of a misidentification of cutibacterium acnes (propionibacterium acnes) as vibrio fluvialis or vibrio fluvialis/ e.Faecalis using the vitek® ms instrument (ref.410895, serial number (b)(6).An internal biomérieux investigation was performed analyzing the data provided by the customer.Conclusion on the fine tuning of the vitek ms instrument: the fine tuning done before the identification issue was non-optimal.A new fine tuning was done on (b)(6) 2019.The analysis of the calibrator mzml files indicated that a fine tuning was needed during the tests performed on (b)(6) 2019.Conclusion on spot preparation quality: the customer's spot preparation quality was non-optimal.The calibrator and sample "all peaks" values are heterogeneous.This could be explained by a non-optimal spot preparation of the aample and calibrator strains (culture, spot, different operator.).Conclusion on the identification: with the information provided, the expected identification is cutibacterium acnes (= propionibacterium acnes).The identification could be confirmed with the reference method (sequencing).For information, the misidentification was obtained from the spectra having the fewer number of peaks.Moreover, the analysis of the sample mzml files indicates that the quality of the sample preparation was non-optimal.It could explain the misidentification obtained.Suspected causes retained: non-optimal fine tuning.Lack of fine tuning monitoring.Non-optimal spot preparation.

• Brand Name: VITEK® MS
• Type of Device: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme, 38390 ; FR 38390
• MDR Report Key: 9292783
• MDR Text Key: 220259881
• Report Number: 9615754-2019-00117
• 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: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1