MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS INSTRUMENT

Model Number 410895

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

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: on (b)(6) 2022, a customer in (b)(6) notified biomérieux of the misidentification of enterobacter hormaechei xiangfangensis as klebsiella aerogenes, and paenibacillus odorifer as prevotella oris, in association with vitek ms instrument ((b)(4)).Summary of results: sample: (b)(6); vitek ms: identified as klebsiella aerogenes; alternate method (illumina complete sequencing): identified as enterobacter hormaechei xiangfangensis.Sample (b)(6); vitek ms: identified as prevotella oris; alternate method (16s sequencing): identified as paenibacillus odorifer.Review of the provided information indicated: lab id (b)(6) identified as klebsiella aerogenes.This is a known system limitation as enterobacter hormaechei xiangfangensis is not present in the vitek ms knowledge base (kb).Lab id (b)(6) identified as prevotella oris.This is a known system limitation as paenibacillus odorifer is not present in the vitek ms kb.The following system limitation is stated in the vitek ms v3.2 knowledge base user manual ref.(b)(4): ¿testing of species not found in the database may result in an unidentified result or a misidentification.Interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ at the time of the initial assessment, despite multiple attempts, information could not be obtained from the customer regarding any patient impact.Update (8-jun-2022): following initial evaluation of this reported event, the customer notified biomérieux on (b)(6) 2022 that the patient associated with isolate id (b)(6) had received antibiotic treatment based on the vitek ms result (details not provided) which was subsequently modified/removed when the associated sequencing test result was provided/updated.There was no indication of adverse impact to the patient's state of health.

Manufacturer Narrative

An internal investigation was performed following notification from a customer in france that they obtained a misidentification of enterobacter hormaechei xiangfangensis as klebsiella aerogenes and paenibacillus odorifer as prevotella oris in association with vitek ms instrument (ref.410895, serial number: (b)(6)).The customer indicated there was no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.Investigation complaint analysis and device history record review.Review of the complaints database and the device history record did not reveal any evidence that this is a systemic quality problem.Fine tuning: status good at the time of acquisition for lab id 22001261310101.Status undetermined at the time of acquisition for lab id 22001940130101 because no data was provided.Spot preparation quality: the calibrator ¿all peaks¿ values are homogeneous.Calibrator spot preparation seems to be good.However, the ¿sample data analysis¿ shows that the sample spot preparation was non optimal for at least one sample (lab id 22001261310101).Knowledge base review: the expected identification enterobacter hormaechei xiangfangensis and paenibacillus odorifer are not present in vitek ms kb v3.2.Customer data analysis: lab id 22001261310101: enterobacter hormaechei xiangfangensis - according to data provided, the misidentification result was obtained from a spectra having a good number of peaks (81) and an acceptable identification score (1.03).Biomérieux quality control laboratory didn¿t reproduce the vitek ms customer results as klebsiella aerogenes.The five sets of spectra led to four low discrimination as enterobacter hormaechei - cloacae - asburiae and one low discrimination as enterobacter cloacae ¿ asburiae.These low discriminations were obtained with low identification scores.As the expected identification enterobacter hormaechei xiangfangensis is not in vitek ms kb v3.2, vitek ms gave misidentification results.The following system limitation is mentioned in the vitek ms knowledge base user manual ref.161150-924a for vitek ms clinical use v3.2: ¿* testing of species not found in the database may result in an unidentified result or a misidentification.* interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ reprocessing the customer data with vitek ms kb v3.3 (in development), spectra led to a single choice to enterobacter hormaechei ssp oharae/xiangfangensis.Analysis of the customer's mzml sample files shows that customer spectra b3 was very different from biomerieux qc lab spectra.Based on these findings, in addition to the system limitation issue (species not present in the vitek ms kb v3.2), there was probably a non-optimal spot preparation issue for this sample strain.Lab id 22001940130101: biomérieux quality control laboratory reproduced the vitek ms customer results as prevotella oris.One spectra led to no identification and four spectra led to single choice as prevotella oris.Reprocessing the customer data with next vitek ms kb v3.3 (in development), led to the same result.Expected identification: based on the 16s rna sequencing results, the expected identification is paenibacillus odorifer.This species is not included in the vitek ms knowledge base v3.2.The following system limitation is mentioned in the vitek ms knowledge base user manual ref.161150-924a for vitek ms clinical use v3.2: ¿* testing of species not found in the database may result in an unidentified result or a misidentification.* interpretation of results and use of the vitek ms system require a competent laboratorian who should judiciously make use of experience, specimen information, and other pertinent procedures before reporting the identification of test organisms.Additional information known to the user, such as gram stain reaction, colonial and cellular morphology, and growth aerobically or in co2 should be considered when accepting vitek ms results.¿ conclusion the investigation indicates this customer issue occurred due to a known system limitation regarding how the software handles spectra for species not present in the knowledge base).Two change requests related to the reported issues have been initiated by r&d for knowledge base review/improvement.

• 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: 14780023
• MDR Text Key: 295060304
• Report Number: 9615754-2022-00084
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 05/24/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention