MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK® MS INSTRUMENT

Model Number	410895
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.Description: an internal complaint was initiated following a review of a scientific publication from argentina entitled, "the dilemma of identifying peptonophilus species by using two maldi-tof ms systems" by barberis c, et al.This publication documents misidentifications of eight (8) peptoniphilus harei isolates as peptoniphilus asaccharolyticus when using the vitek® ms (ref 410895) as compared to identification results obtained by phylogenetic sequencing.This was a retrospective study comparing the identification results of the bruker biotyper and vitek ms compared to results from phylogenetic sequencing for 18 clinical isolates of the peptoniphilus genus, collected from multiple hospitals/clinics in argentina between 2016 and 2020.The vitek ms correctly identified 5 isolates to the species level, misidentified 8 isolates, and did not provide an identification for 5 isolates.The expected identifications were established with 16s rrna sequencing.In contrast, the bruker biotyper was reported to correctly identify 17 isolates to the species level and did not provide an identification for 1 isolate.The 5 isolates for which vitek ms provided no identification were identified by 16s rrna sequencing as p.Duerdenii, p.Tyrrelliae (2 isolates), p.Nemausensis, and p.Lacydonensis, all of which are absent from the vitek ms knowledge base.The 8 isolates that were misidentified as p.Asaccharolyticus by vitek ms were confirmed by 16s rrna sequencing as p.Harei, which is a closely related species and is phenotypically indistinguishable from p.Asaccharolyticus.These misidentifications need to be further investigated.As this was a retrospective study, there is no adverse event associated with any misidentifications obtained during the study.An investigation has been initiated.
Additional Manufacturer Narrative
An internal complaint was initiated following a review of a scientific publication from argentina entitled, "the dilemma of identifying peptoniphilus species by using two maldi-tof ms systems" by barberis c, et al.This publication documents misidentifications of eight (8) peptoniphilus harei isolates as peptoniphilus asaccharolyticus when using the vitek® ms (ref (b)(4)) as compared to identification results obtained by phylogenetic sequencing.Investigation: first the investigator searched the biomérieux complaint database for similar reports.Since january 2016, no similar complaint has been recorded.The publication was a retrospective study looking at 18 clinical isolates of the peptoniphilus genus, comparing their identification between both commercially available maldi-tof systems, bruker biotyper and vitek ms, and comparing the results obtained by mass spectroscopy to the gold standard phylogenetic sequencing method.The ability to identify isolates depends on the number and quality of protein spectra available in the ms platform database, in which rare organisms are not well represented.In this study, 18 peptoniphilus isolates were tested with both the bruker biotyper and the vitek ms.The biotyper correctly identified 17 of the 18 isolates to the species level, while the vitek ms only correctly identified 5 isolates to the species level.The vitek ms misidentified 8 isolates and failed to provide an identification for 5 isolates.16s rrna sequencing confirmed the misidentifications and no identifications from the vitek ms.The 5 isolates for which vitek ms provided no identification were identified by 16s rrna sequencing as p.Duerdenii, p.Tyrrelliae (2 isolates), p.Nemausensis, and p.Lacydonensis, all of which are absent from the vitek ms database.The 8 isolates that were misidentified as p.Asaccharolyticus by vitek ms were confirmed by 16s rrna sequencing as p.Harei, which is a closely related species and is phenotypically indistinguishable from p.Asaccharolyticus.The use of 16s rrna sequencing was appropriate as this methodology is considered the gold standard reference method.Observed study results compared to the claimed product performance: the 5 isolates that were correctly identified (p.Lacrimalis, 3 isolates, and p.Harei, 2 isolates) are represented in the vitek ms database.The 5 isolates with no identification are not present in the vitek ms database.The 8 isolates of p.Harei that were misidentified as p.Asaccharolyticus are likely the result of inaccurately labeled organism spectra present in the database.P.Harei and p.Asaccharolyticus are phenotypically indistinguishable, which has led to incorrect identification of the organism by clinical microbiology laboratories using traditional phenotypic methods, the genetic sequences for which have been entered into the pubmed phylogenetic database with an incorrectly annotated organism name.Additional information was requested from the subsidiary but no further data were provided.Conclusion: the 5 isolates a37, a60, g45, m20 and m30, that were correctly identified as p.Lacrimalis and p.Harei, are represented in the vitek ms database (no malfunction).The 5 isolates a20, g11, g37, g40 and g50 with no identification, are not present in the vitek ms knowledge base v 3.2 (system limitation).The performance of the vitek ms is according to manufacturer claims, p.Duerdenii, p.Tyrrelliae, p.Nemausensis and p.Lacydonensis are outside of current knowledge base v3.2.The following system limitation is mentioned in the vitek ms knowledge base user manual ref.161150-924 ¿ a for vitek ms clinical use v3.2: ¿the vitek ms system has not been validated for use with direct samples or from other sources containing mixed flora.Additional laboratory tests as determined by microbiology laboratory protocols for low discrimination results are necessary for the completion of the organism identification.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.¿ in addition, there is a specific comment in the vitek ms workflow user manual clinic use ref.4501-2233 ¿ f explaining how to manage the ¿no identification¿ results (in the ¿vitek ms acquisition/analysis messages¿ section): ¿[p150] sample spot: no identification: repeat the acquisition for the same deposit.If the message is displayed again, redo the deposit and then the acquisition.If the message is displayed again, repeat the identification using another method (such as vitek 2, api strip, other biochemical or molecular methods).In this case, sequencing is the reference molecular method to identify the strain.The addition of p.Duerdenii, p.Tyrrelliae, p.Nemausensis and p.Lacydonensis species in the vitek ms kb next release will be assessed (respectively #cr4188 , #cr3536, #cr4189 and #cr4191) but also #cr4190 for p.Senegalensis and #cr3893 for p.Rhinitidis).The 8 isolates a38, a40, c56, g17, g42, g43, g48 and g51 of p.Harei that were misidentified as p.Asaccharolyticus, are likely the result of inaccurately labeled organism spectra present in the 16s rrna database.P.Asaccharolyticus and p.Harei are two species that shared biochemical features and cannot be phenotypically differentiated.The genetic sequences entered into the pubmed phylogenetic database had an incorrectly annotated organism name (reference strain wrongly assigned in the pubmed database).Therefore, the strains identified by 16s rrna sequencing as p.Harei coud eventually be p.Asaccharolyticus species.Misidentification were explained by the author by a reference strain wrongly assigned in the vitek ms database.However, the cross performance for the vitek ms kb v3.2 and the next v3.3 were good for p.Haeri.More than 30 spectra were tested and have shown 100% of good identification as a single choice.No misidentification, low discrimination or noid were observed during these studies.In addition, all spectra were sequenced by 16s rrna gene.The identification quality of the knowledge base were not questioned.Without additional data, these hypothesis could not be confirmed.P.Duerdenii, p.Tyrrelliae, p.Nemausensis and p.Lacydonensis species are scheduled to be included in the next vitek ms kb release (respectively #cr4188 , #cr3536, #cr4189 and #cr4191) but also #cr4190 for p.Senegalensis and #cr3893 for p.Rhinitidis.

• Brand Name: VITEK® MS INSTRUMENT
• Common Device Name: 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: 13387116
• Report Number: 9615754-2022-00018
• Device Sequence Number: 5345050
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K181412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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
• Operator of Device: Health Professional
• Device Model Number: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown