MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK® MS - 412550; VITEK MS INSTRUMENT FOR JAPAN - 412550

Model Number 412550

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 a misidentification of streptococcus gallolyticus ssp pasteurianus as streptococcus gallolyticus ssp gallolyticus in association with the vitek® ms (ref 412550, serial (b)(4)).16s rrna sequencing was performed as an alternative identification method and obtained an identification of streptococcus gallolyticus ssp pasteurianus.The customer reported the result as streptococcus gallolyticus ssp gallolyticus, but the customer stated that the misidentification did not lead to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a misidentification of streptococcus gallolyticus ssp pasteurianus as streptococcus gallolyticus ssp gallolyticus in association with the vitek® ms (ref 412550, serial (b)(6).The customer's raw data was analyzed during this investigation.The fine tuning analyzer report for the last fine tuning done before the identification issue has not been provided.Consequently, it was not possible to conclude on the fine tuning quality before the identification issue.Based on the analysis of the calibrator mzml files and according to the vilink alert tool criteria, no fine tuning was needed during the tests made on (b)(6) 2019.The customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values are heterogeneous.According to data provided, the misidentification was obtained with a low identification score.By reprocessing the customer data with vitek ms kb v3.2, the spectra led to a single choice to streptococcus gallolyticus ssp pasteurianus with a good identification score.There is no misidentification anymore.22 new spectra of streptococcus gallolyticus ssp pasteurianus were added to the database vitek ms kb v3.2 and this species class is now more robust.The investigation concluded that the misidentification occurred due to non-optimal spot preparation and a knowledge base weakness for this species in vitek ms kb v3.0.Local customer service (lcs) has been requested to provide additional training materials to the customer to help improve spot preparation technique and to upgrade the customer's system to vitek ms kb v3.2.

• Brand Name: VITEK® MS - 412550
• Type of Device: VITEK MS INSTRUMENT FOR JAPAN - 412550
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 9734315
• MDR Text Key: 206142721
• Report Number: 9615754-2020-00032
• Device Sequence Number: 1
• Product Code: PEX
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 412550
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1