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

Model 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 mould infections.Issue description: a publication in japan documents misidentifications when using vitek ms instrument (ref.(b)(4), serial number unknown).Biomerieux r&d and medical affairs have reviewed the publication 273812939: ¿comparison of maldi-tof mass spectrometry and rpob gene sequencing for the identification of clinical isolates of aeromonas spp¿, a summary is following: nature of the event observed and impact: this report describes the performance of maldi-tof, (both bruker and vitek ms) for the identification of aeromonas spp.From a collection of 58 clinical aeromonas isolates, all 58 were correctly identified to the genus level by vitek ms.In addition, all 19 a.Caviae and all 15 a.Hydrophila were correctly identified to the species level; however, the other 3 species of aeromonas (a.Dhakensis, a.Veronii, and a.Jandaei) were identified as more than one species.All isolates of a.Veronii and a.Jandaei were identified as a.Sobria and a.Veronii.A.Dhakensis isolates were identified as a variety of other aeromonas species.The ability to correctly identify aeromonas isolates to the species level is important for the understanding of local prevalence; however, there are no specific antimicrobial therapeutic regiments associated with specific species of aeromonas.Treatment of aeromonas infections would be dependent upon definitive antimicrobial susceptibility testing results.Respect of the instructions for use: the authors performed testing according to the instructions for use.Vitek ms kb3.2 was used in this study.The relevance of the methodology: the methodology used was consistent with standard practice.Observed study results compared to claimed product performance: this study showed good performance of vitek ms at correctly identifying aeromonas caviae and a.Hydrophila.The primary issue with mis-identification in this publication was with a.Dhakensis, but the lack of correct identification for this species would be expected, since this species is not represented in kb3.2.However, the mis-identification of a.Jandei, which is represented in kb3.2, warrants further investigation.There is no indication or report that this event led to any adverse event related to any patient's state of health.An investigation has been initiated.

Manufacturer Narrative

Context: a publication in japan documents misidentifications when using vitek ms instrument (ref.(b)(4), serial number unknown).Biomerieux r&d and medical affairs have reviewed the publication 273812939: ¿comparison of maldi-tof mass spectrometry and rpob gene sequencing for the identification of clinical isolates of aeromonas spp¿ vitek ms mode : ivd kb version : kb3.2 issue type : misidentification of aeromonas species mis identifications were reported for a.Dhakensis (x12 strains) and a.Jandaei (x1 strain).Other method : vitek 2 gene sequencing (rpob) bruker biotyper culture: 58 clinical aeromonas isolates origin : culture media : muller hinton agar plate incubation: 35°c for 24h under aerobic conditions issue date: unknown fine tuning date before the issue: unknown investigation: 1.Complaint trend analysis and device history record referring to 049355 - 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 for now.The period from september 2022 to november 2022 has been check for the error code ivd mis-identification - f871.There is no trend and no capa related to this complaint.2.Investigation for aeromonas dhakensis, the misidentification was explained by a system limitation.This species is not present in the vitek ms kb3.2.However, this species will be added in the next kb3.3.In addition, only one strain of aeromonas jandaei was misidentified as aeromonas sobria/ aeromonas veronii and 45 out of 46 isolates were correct identified.Therefore, this does not need to do further investigation since there is no major evidence of product performance regression (1 strain misidentified).Conclusion: the most probable root cause of this issue is a system limitation.According to data above, there is no reconsideration of vitek ms (ref.(b)(4)) performance.

• Brand Name: VITEK® MS INSTRUMENT
• 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: céline strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15976443
• MDR Text Key: 305665104
• Report Number: 9615754-2022-00147
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K181412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

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
• Device Catalogue Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 12/21/2022
• 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