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 Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Intended use: 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 singapore notified biomérieux of obtaining misidentification results in association with the vitek® ms instrument ref.410895, (b)(4).When testing four (4) yeast samples from separate patients using knowledge base (kb) version 3.2.The four (4) yeast isolates sourced from urine were cultured on cled agar then tested with the vitek® ms instrument and the bruker sequencing test method.Vitek® ms identification results: candida famata microsporum canis aspergillus terreus complex malassezia furfu bruker sequencing results: candida albicans candida tropicalis candida tropicalis candida albicans the customer repeated testing of the isolates on the vitek® ms instrument with isolates cultured on sda agar.The repeat test results aligned with the results obtained with the bruker sequencing test method.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to any patient's state of health.Biomérieux has initiated an internal investigation.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in singapore that they obtained misidentifications of 4 yeast samples from separate patients with their vitek® ms instrument (ref.410895, serial# (b)(6), knowledge base v3.2).Investigation.1.Complaint analysis and device history record.Review of the complaints database and device history record did not reveal any evidence that this is a systemic quality problem.On 15 jun 2022, local customer service informed us that due to the customer's myla mirroring schedule, the required mzml file is currently in the previous mirrored backup.The customer stated that the retrieval process would cause their downtime to be too long, and the customer decided not to go ahead with this investigation as no data was provided, it was not possible to investigate and to define the exact cause of the potential misidentification observed by the customer.The root cause of the customer's issue remains unknown.

• 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
• 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: 14680940
• MDR Text Key: 301522946
• Report Number: 9615754-2022-00077
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

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: 05/26/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 07/06/2022
• 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