MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS IND CHCA (MATRIX)

Model Number 417067

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 mould infections.The vitek® ms system is intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.Issue description: a customer in (b)(6) reported to biomérieux that they have obtained a potential misidentification of klebsiella oxytoca atcc® 700324¿ as raoultella ornithinolytica with the product vitek ms ind chca (matrix) (ref.417067) associated with the equipment vitek ms instrument (ref.410895, serial number (b)(4)).It was reported that the customer performed identification using atcc 700324 bacteria for internal evaluation of vitek ms, and the results were as follows: atcc 700324: klebsiella oxytoca (expected result), vitek ms : raoultella ornithinolytica 99.9%, repeat: no progress.Plate culture conditions were as follows: using 2nd subcultured plate from stock, blood agar ppm plate (local media brand, asan), 35c, 24h, 11/9 cultured.This plate has been stored and has been ordered for sequencing (16s rrna) and will be attached to this case as soon as the results are available.Since a failure occurred during the process of using this atcc 700324 strain as one of the internal evaluation bacteria, the customer also requested a confirmation as to whether it is difficult for vitek ms to identify this strain in routine.As there is no patient associated with this atcc strain, there is no adverse event related to any patient's state of health.An investigation has been initiated.

Manufacturer Narrative

A customer in the republic of korea reported to biomérieux that they have obtained a potential misidentification of klebsiella oxytoca atcc® 700324¿ as raoultella ornithinolytica with the product vitek® ms ind chca (matrix) (ref.417067) associated with the equipment vitek ms instrument (ref.410895, serial number (b)(6)).There were no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.Fine tuning: status appeared good at the time of acquisition.Spot preparation quality: the sample ¿all peaks¿ values seems to be good (90 peaks).Knowledge base (kb) review: as the customer tested a known collection strain klebsiella oxytoca atcc 700324, the expected identification should be klebsiella oxytoca.However, the strain was identified as raoultella ornithinolytica by 16s sequencing and vitek ms.Both organisms are present in the vitek ms kb v3.2 knowledge base.Sample data analysis: according to data provided, the potential misidentification result was obtained from spectra having a good number of peaks (90).In addition, the potential misidentification was obtained with a good identification score (0.47).The quality of spectra seems to be good.To verify the performance of vitek ms system, two samples of atcc 700324 strains from biomérieux collection strains were tested with vitek ms v3.2.Four spots were performed for each sample.R&d lab mzml files were reprocessed with vitek ms kb v3.2 and the four spectra for each sample led to a single choice as klebsiella oxytoca.Biomérieux r&d laboratory didn¿t reproduce the vitek ms customer results as raoultella ornithinolytica.Both samples of atcc 700324 internal strains were correctly identified by the system.Based on these findings, the source of the customer stock and the quality of the strain will be questioned.Conclusion based on the data above, biomérieux recommended the customer double check the strain.As the spot preparation and fine tuning appeared good, and both organisms are included in the knowledge base, the quality control strain may have become contaminated.Sequencing of the sample showed both organisms to be present, thus there is no evidence at this time that the vitek ms instrument malfunctioned.

• Brand Name: VITEK MS IND CHCA (MATRIX)
• Type of Device: VITEK MS IND CHCA (MATRIX)
• 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: 12960335
• MDR Text Key: 288043595
• Report Number: 9615754-2021-00293
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 01/10/2022

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: 417067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1