MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT - 410895

Catalog Number 410895

Device Problem Incorrect Measurement (1383)

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 the united states notified biomérieux of a misidentification of an unknown isolate as brucella spp associated with vitek ms instrument - ref.410895, lot unknown.The customer indicated that upon identification of brucella the isolate was sent to another lab for additional testing.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any person's state of health.

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 the united states notified biomérieux of a misidentification of an unknown isolate as brucella spp associated with vitek ms instrument - ref.410895, lot unknown.The customer indicated that upon identification of brucella the isolate was sent to another lab for additional testing.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any person's state of health.

Manufacturer Narrative

Vitek ms mode : ivd.Kb version : 3.2 (ind) us.Issue type : misidentification as brucella spp.Vitek ms result: one single choice to brucella spp.Note : data were not provided.Other method : no secondary testing performed.Expected id: unknown.Culture conditions: origin: gram positive coccobacilli with biofilm present.Culture media : tsa.Incubation: 36°c for 24 hours.Issue date: unknown.Fine tuning date before the issue: unknown.Investigation: 1.Complaint trend analysis and device history record.Referring to (b)(4)- technical complaint trend analysis using the cstat application , there is no out-of-control alert, or a non-confirmed out-of-control alert in cstat.We checked the period from june 2023 to august 2023 for the error code ivd mis-identification - f871.2.Investigation: data have been requested to investigate on 09 aug 2023 but customer didn¿t answer despite several reminders.Consequently, based on the rules for closure of the procedure 026816 rev.16.A decision was made to close the investigation due to impossibility to investigate.Related to the misidentification as brucella, csn # 4989 was published about potential misidentification as brucella spp with kb v3.2.These incorrect organism identifications have been in conjunction with degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue has been fixed with the vitek ms kb v3.3 update.According to the user manual 161150-1618 - b, as brucella spp is a highly pathogenic organism, handle isolate with extreme caution and send it to a reference laboratory for further investigation.3.Root cause analysis: unknown.4.Corrective or preventive actions: no capa number is needed.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK MS INSTRUMENT - 410895
• 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: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 17572201
• MDR Text Key: 321637322
• Report Number: 9615754-2023-00039
• 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: 10/04/2023

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 Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/04/2023
• 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