MAUDE Adverse Event Report: BIOMERIEUX, SA VITEK MS INSTRUMENT - 410895

Model Number 410895

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

Intended use: the vitek® ms system, reference (b)(4), is a mass spectrometer using maldi-tof (matrix-assisted laser desorption/ionization-time of flight) technology for the identification of microorganisms cultured from clinical specimens.Description of the issue: a customer in united states notified biomérieux of viability issues of neisseria meningitidis when testing the strain with the vitek ms instrument -reference (b)(4) (serial number: (b)(4).The customer indicated they have verified neisseria meningitidis strain viability after spotting, overlaying with matrix and drying, indicating that 33% of the isolates were still viable.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.This discrepancy was reviewed for vigilance reporting according to 21 cfr 803 concerning medical device reporting.Biomérieux internal standard operating procedures state that biological exposure in association with vitek® ms is considered to be a potentially reportable event.Biological exposure is due to exposure to contents of ancillary items, or exposure to other contaminated surface/ equipment or due to physical injury (e.G.Cut or puncture wound).Spills should be treated in accordance with each institution¿s biohazard control plan.If accompanied by exposure, may require medical intervention as per the institution¿s protocol.Exposed property and the environment may require cleaning and/or disinfection and/or sterilization.This review has determined that this event meets the criteria for reporting as a malfunction.Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur while testing a patient isolate.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Context *********************** a customer in united states notified biomérieux of viability issues of neisseria meningitidis when testing the strain with the vitek ms instrument -reference 410895 ( serial number : (b)(6)).Indeed, the customer has verified the viability of the strain after spotting and overlaying with matrix and drying a neisseria strain.He indicated that 33% of the isolates were still viable.Investigation results *********************** **complaint analysis and device history record** the review did not indicate any systematic quality issue related to this investigation.**stability study** according to the stability study after spotting performed internally, after the addition of chca matrix for bacteria preparation protocol or chca matrix and formic acid for yeast preparation protocol, the microorganisms spotted on the target are not viable, if the spot is entirely covered with matrix.Only spores of b.Licheniformis and b.Megaterium obtained after several days of incubation on specific sporulation medium are viable after the addition of chca matrix.This should not be a significant problem as samples are usually tested from fresh cultures.In conclusion, except for bacillus spores, there is no biological risk for the operator to handle the vitek ms ds target slide smeared with bacteria and yeast after the addition of chca matrix as long as the user carefully covers the spot entirely with matrix to get proper inactivation.**spot preparation** according to the vitek ms v3.2 knowledge base user manual ref.161150-924-a, for critical pathogens ¿handle isolate with extreme caution and send to a reference laboratory for identification confirmation following your laboratory¿s protocol and/or country regulations.¿.According to the user manual - 161150-1377 - b - en - vitek ms workflow clinical use us, ¿all specimens, microbial cultures and inoculated products should be considered infectious and handled appropriately.Aseptic technique and usual precautions for handling the bacterial group studied should be observed throughout this procedure.Refer to ¿clsi m29-a, protection of laboratory workers from occupationally acquired infections; approved guideline ¿ current version¿.For additional handling precautions, refer to ¿biosafety in microbiological and biomedical laboratories ¿ cdc/nih ¿ latest edition¿, or to regulations currently in use in each country.¿ ¿when phenotypic characteristics indicate a potential highly pathogenic organism, laboratories should employ the appropriate safety measures to prevent a laboratory-acquired infection.For laboratories not able to handle highly pathogenic organisms, suspect isolates should be sent to a reference laboratory.In the event that a highly pathogenic organism is run on the vitek ms instrument, an internal study has shown that no internal contamination of the instrument occurred, and therefore, there was no risk of biological contamination.The inactivation protocols described in this section have been validated for each specific species they are intended for and are dedicated to those species only.They must not be used to test any other species (including bsl3 or spore-forming bacteria).Direct preparation with vitek ms chca matrix is insufficient for the inactivation of spore-forming bacteria such as clostridium tetani.¿ according the user manual - 161150-1124 - b - en - vitek ms software - clinical use, ¿all biological samples and quality control (qc) products incubated in this system, as well as all waste in the waste containers, should be treated as potentially biohazardous materials.All materials and mechanical components associated with the waste systems should be handled according to safe microbiological practices in compliance with the installation site¿s biohazard procedures.Use the personal protective equipment recommended by the facility when handling any of these components, including gloves, safety glasses, and a lab coat.The system must be decontaminated before its covers are removed by service personnel.Ensure that appropriate decontamination is carried out if hazardous materials are spilled on or into the equipment or surrounding areas.Conclusion : ******************** no systematic quality issue has been identified during the investigation.The instruction for use of the vitek ms product indicates that the handling of the isolate should be made with extreme caution.The preparation protocol indicates that after the addition of chca matrix for bacteria preparation protocol or chca matrix and formic acid for yeast preparation protocol, the microorganisms spotted on the target are not viable, if the spot is entirely covered with matrix.It has been recommended to verify that the spots is entirely covered with the matrix during the spot preparation to ensure the proper inactivation of microorganisms.

• Brand Name: VITEK MS INSTRUMENT - 410895
• Type of Device: VITEK MS INSTRUMENT - 410895
• Manufacturer (Section D): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer (Section G): BIOMERIEUX, SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: pauline ; 5 rue des aqueducs; craponne 69290
• MDR Report Key: 15892070
• MDR Text Key: 305665212
• Report Number: 9615754-2022-00141
• 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,Followup
• Report Date: 12/12/2022

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: 410895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/12/2022
• 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