MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK® MS INSTRUMENT

Model Number 410895

Device Problem Optical Obstruction (3002)

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 customer in australia notified biomérieux of a delay >48 hours in providing the bottle results or the patient blood culture identification (streptococcus group b) when using vitek ms instrument (ref.(b)(4), serial number: (b)(4)).Customer reported twice before (on 07-nov and on 04-dec) that "the vitek ms was slow and struggling to identify bacteria"; these events were documented in complaints (b)(4) and (b)(4), respectively.For each issue, remote access by biomérieux did not identify any issue; the specifications passed.The customer specified that: ¿a patient had a positive blood culture and the maldi failed to identify the bacteria even though it was a heavy, pure streptococcus group b.This delayed the result by over 48 hours, which is not acceptable for any sterile site identification.The patient had an additional blood collection done and sent to the hospital laboratory, and they got an identification released before we did, even though we received the first set of blood collections.¿ biomérieux received the complaint and request for a site visit to investigate the vitek ms performance issue on 05-december.The local biomérieux field service engineer (fse) performed a site intervention including linear detector replacement, ion optics cleaning, conditioning and tuning.After biomérieux fse intervention, the system was performing within specifications.An investigation will be initiated.

Manufacturer Narrative

Context: a customer in australia notified biomérieux of a delay >48 hours in providing the bottle results or the patient blood culture identification (streptococcus group b) when using vitek ms instrument (ref.(b)(4), serial number: (b)(6)).Investigation: batch history record and complaint trend analysis.There is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results: *fine tuning (ft): status good at the time of acquisition.However, the level of number of peaks was far from the target, especially on 02 dec 2022.*spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.It needs to be verified with the customer.*knowledge base (kb) review: the expected identification is unknown because no reference method was used to confirm the expected identification.*sample data analysis: analyze of mzml sample files show that number of all peaks are heterogeneous during the issue (between 0 to 525).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different user ¿).Reprocessing of the customer data with vitek ms kb v3.2 allows to show that the "no identification" results were due to ¿empty spectra¿ or ¿too noisy ¿ too many peaks spectra¿.It could be due to a bad organism quantity deposit on the spots (too thick or too fine organism deposit).- "emptyspectra" : it means that nothing has been acquired from the spot.It could be link to bad crystallization of the samples.Consequently, the ionization will not be efficient.- "too many peaks spectra¿: it means that not enough organism have been deposit on the spots, the spectra will be noise only (i.E.Very high number of peaks detected, ¿.).Consequently, the amount of ¿good peaks¿ detected during acquisition will be not sufficient to allow a good identification.For the sample spectra acquired on 03 dec 2022, there are presence of peaks near 7.5 kda and near 15 kda (double-charged peak).Based on this observation, we suspect the presence of hemoglobin peaks in these spectra.The hemoglobin peaks are prominent and prevent the expression of the other proteins, leading to very few number of peaks and consequently giving the misidentification or no identification.Based on all these findings, a non-optimal sample preparation quality is suspected, probably linked to agar picking during the collection of the colonies on the plate or blood from the collected sample.It needs to be verified with the customer.Customer data was obtained from colonies that have been incubated only 8 hours, low incubation time could affect bacteria protein expression.The incubation time recommendations for bacteria is 18 to 72 hours (cf.Vitek ms workflow clinical use ¿ ref.4501-2233 - f).It was an operator error and an ¿off label use¿, this incorrect incubation time explain the identification issue observed by the customer.The identification result as s.Agalactiae was obtained from the spectra having a number of peaks at 117 and 177.The intensity was very low except for a majority peak around 4500da that prevents the expression of the other peaks.However, analysis shows that 30 peaks of sample spectra matched with s.Agalactiae reference spectra but the identification as s.Agalactiae needs to be confirmed.Biomérieux quality control laboratory didn¿t reproduce the customer no-identification.Spectra led to the expected identification as streptococcus agalactiae.The issue seems to be linked to a bad quality of the spectra.

• 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: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15959356
• MDR Text Key: 305665140
• Report Number: 9615754-2022-00146
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/13/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/13/2023
• 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