MAUDE Adverse Event Report: BIOMERIEUX SA VITEK MS INSTRUMENT®

Model Number 410895

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Following the incorrect vitek® ms identification test result obtained by the customer when testing a microorganism isolated from one patient's sample an investigation has been conducted at biomèrieux manufacturing site.Fine tuning: according to the vilink alert tool criteria, no fine tuning was needed on vitek ms during customer¿s tests.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The sample and calibrator ¿all peaks¿ values were heterogeneous.Sample preparation needs to be verified with the customer.Knowledge base (kb) review: the expected identification is unknown because no reference method was used to confirm it.Sample data analysis: reprocessing the customer data from with vitek ms kb v3.2 allows to obtain four "no identification" results, one ¿notenoughpeaks¿ and one single choice to brucella abortus.Analysis of the submitted mzml sample files shows that the spectra (i1) which gave the misidentification to brucella spp have the lowest number of peaks (34 peaks) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (30).Moreover, this misidentification was obtained with a low identification score (-0.13).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator¿).Reprocessing the customer data with vitek ms kb v3.3 allows to obtain "no identification" results; no misidentification results were observed.Related to the misidentification as brucella, a customer communication (csn # (b)(6)) was published about potential misidentification as brucella spp with kb v3.2.These incorrect organism identifications were always related to degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue is resolved with vitek ms kb v3.3.According to the user manual 161150-925 ¿ a vitek® ms v3.2 kb - clinical use, as brucella spp is a highly pathogenic organism, handle isolate with extreme caution and send it to a reference laboratory for further investigation.Expected identification after investigation: unknown, no reference method has been made to confirm the expected identification.Suspected cause retained; non optimal spot preparation; kb v3.2 weakness linked with the bad quality of spectra.

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.Complaint description: a customer in the united states complained after having obtained an incorrect identification test result when testing a microorganism isolated from a patient sample (sputum specimen) for identification test using biomérieux mass spectrometry technique.The customer said that they had tested a colony isolated from a patient sample using their vitek® ms instrument (ref.410895, serial# number 51427), knowledge base (kb) version 3.0 and that the microorganism was identified as brucella sp.98.6% with medium confidence level.Customer stated that the organism did not match brucella morphologically and it was a gram negative rod from a sputum specimen.Follow-up testing was catalase positive and oxidase positive.The customer stated that they sent the sample to the public health laboratory which confirmed that the microoganism was not brucella.There is no indication or report from the customer that this event led to or contributed to any death, serious injury, or serious deterioration in the state of health for the concerned patient.

• Brand Name: VITEK MS INSTRUMENT®
• Type of Device: VITEK MS INSTRUMENT®
• Manufacturer (Section D): BIOMERIEUX 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: stefania ciranda ; 5 rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17363075
• MDR Text Key: 319444650
• Report Number: 9615754-2023-00035
• 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
• Report Date: 07/20/2023

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 Model Number: 410895
• Device Catalogue Number: 410895
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2023
• Initial Date FDA Received: 07/20/2023
• 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