MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT; VITEK® MS INSTRUMENT

Model Number 410895

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A customer from the united states notified biomérieux of obtaining a misidentification of clostridium perfringens as bacillus clausii when using the vitek® ms instrument (ref.410895, serial # (b)(4)).The customer reported obtaining the following results when testing a patient sample: 1st spot: clostridium perfringens 99.9% / 2nd spot: bacillus clausii 99.9%.The customer had performed biochemical tests that confirmed the microorganism to be clostridium perfringens.The customer reported the identification as clostridium perfringens.The customer performed repeat testing with the following results: 1st spot: clostridium perfringens / 2nd spot: clostridium perfringens.There is no indication or report from the customer to biomérieux that the reported issue led to any adverse event related to the patient's state of health.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the united states regarding a misidentification of clostridium perfringens as bacillus clausii when using the vitek® ms instrument (ref.(b)(4), serial # (b)(6).According to the vilink alert tool criteria, a fine-tuning was needed during the tests made on (b)(6) 2020.The customer¿s calibrator¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were quite heterogeneous.This could be explained by a non-optimal spot preparation of the calibrator strain.The expected identification is clostridium perfringens which is present in vitek® ms v3.2 knowledge base.The analysis of the mzml samples files showed the identification was obtained with a low identification score (-0.35) which is also near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.40).The root cause of the customer¿s results was determined to be due to non-optimal spot preparation, and fine-tuning.Recommended to check sample preparation with the customer, especially the quality of the strains used (age of the strain, culture media used) and the operators skills regarding spot preparation.See section h10.

• Brand Name: VITEK MS INSTRUMENT
• Type of Device: VITEK® MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3, route de port michaud; la balme 38390 ; FR 38390
• MDR Report Key: 11139507
• MDR Text Key: 225756020
• Report Number: 9615754-2021-00003
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• PMA/PMN Number: K181412
• 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: 02/16/2021

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: 12/11/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 01/20/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1