MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT

Model Number 410895

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Vitek® ms is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (maldi-tof ms) for the identification of microorganisms cultured from human specimens.The vitek® ms system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mold infections.Issue description: a customer in the united states notified biomérieux of obtaining misidentification results in association with the vitek® ms instrument (ref.410895, (b)(4) using knowledge base v3.0 when testing a patient isolate.The customer stated the vitek® ms instrument identified the isolate as bacillus spp.The customer stated this did not align with the organism being coagulase negative organism.Biomérieux requested additional information regarding the patient isolate, the customer confirmed the strain is no longer available.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux will initiate an internal investigation for this issue.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in the united states that they obtained a potential misidentification with a patient sample in association with vitek® ms instrument (ref.410895, serial# 50733) using knowledge base v3.0.Note : local customer service asked customer if they had any patient information or accession id.The customer confirmed the patient sample involved was no longer available for testing, nor were they able to provide further patient information or an accession id.Customer did state that organism was retested and results were acceptable.In addition, local customer service explained to customer the importance of calling when they suspect a misidentification.There was no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.Based on information from the customer no data, nor portion of the sample involved is available for performing an investigation.

• 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
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 14647780
• MDR Text Key: 300442330
• Report Number: 9615754-2022-00075
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/09/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1