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

Model Number	410895
Medical Device Problem Code	Incorrect Measurement (1383)
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 mold infections.Issue description: a customer in canada notified biomérieux of a misidentification of staphylococcus aureus as brucella spp associated with vitek ms prime - ref.(b)(4).The customer performed testing at 24 hours of incubation with results of brucella spp.The customer then continued incubation and performed testing of the same isolate / agar plate at 48 hours with results of staphylococcus aureus.At the time of assessment, there is no indication or report from the customer that this event led to any adverse event related to any patient's state of health.14-aug-2024 note: canada local customer service notified that the intial product reference vitek ms prime 423281 documented in the complaint record was incorrect.The actual product reference is vitek ms instrument 410895.This local assessment has been modified and a new emdr created.
Additional Manufacturer Narrative
Vitek ms, mode : ivd, kb version : 3.2 (cli).Issue type : misidentification as brucella spp.Vitek ms result - specimen id: (b)(6).-single choice to brucella spp.-single choice to staphylococcus aureus.Other method : morphology of organism was beta hemolytic which is not consistent with brucella spp.Expected id: unknown as no identification reference method was performed.Culture conditions: -origin: unknown, -culture media : columbia blood agar, -incubation: 24 to 48 hours in 5% co2.Issue date: 06 aug 2024.Fine tuning date before the issue: 05 aug 2024 found on ftassistant.Impact & workaround.There were no patient or operator death, no patient or operator harmed, no indirect harm patient reported, no patient harmed/treated incorrectly.Severity: however, based on vitek ms hazard definition and impacts bmx.1.009176 rev.4, the severity of an ¿erroneous test result - incorrect id result¿ for the patient is considered serious.Probability: a query has been done regarding the number of complaints recorded for a misidentification due to a non optimal sample preparation, kb weakness.Probability s per bmx.1.009689 vitek ms v3.X risk management plan §6.3 is assessed improbable.Final risk level: based on sop 001622 and considering the following criteria: severity: serious, probability of occurrence (p1): improbable, probability of the hazard leading to harm (p2): occasional based on vitek ms hazard definition and impacts bmx.1.009176 rev.4.Overall probability (p): (p1) x (p2): improbable.The final risk level is assessed irrelevant and acceptable.Investigation: 1.Complaint trend analysis and device history record referring to 049355 - technical complaint trend analysis using the cstat application , there is no out-of-control alert, or a non-confirmed out-of-control alert in cstat for now.We checked the period from may 2024 to july 2024 for the error code ivd mis-identification - f871.2.Investigation.Fine tuning: last fine tuning done was non optimal.Two mandatory acceptance criteria were not achieved.A new fine tuning must be perform.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.It needs to be verified with the customer.Kb review: the expected identification was unknown because no reference method was used.Sample data analysis: analyze of mzml sample files shows that the spectrum which gave the misidentification to brucella spp have a low number of peaks (46 peaks).The second spectra has also a low level of peaks.Moreover, this misidentification was obtained with a low identification score (-0.29) which is near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (-0.4).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator¿).It needs to be verified with the customer.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.By reprocessing the customer data with next vitek ms kb v3.3, spectrum which gave misidentification results as brucella spp led to no identification.There is no more misidentification to brucella.Related to the misidentification as brucella, csn # (b)(4) was published about potential misidentification as brucella spp with kb v3.2.These incorrect organism identifications have always been seen so far in conjunction with degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue was fixed with the new vitek ms kb v3.3.3.Root cause analysis: -kb weakness linked with the bad quality of spectra.-non optimal spot preparation.4.Corrective or preventive actions: no capa number is needed.

• Brand Name: VITEK® MS
• Common Device Name: VITEK MS INSTRUMENT
• Manufacturer (Section D): BIOMÉRIEUX SA; 3 route de port michaud; la balme
• Manufacturer (Section G): BIOMÉRIEUX SA; 3 route de port michaud; la balme 38390 ; FR 38390
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 20083510
• Report Number: 9615754-2024-00016
• Device Sequence Number: 7561625
• Product Code: QBN
• UDI-Device Identifier: 03573026359119
• UDI-Public: 03573026359119
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2024

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
• Device Catalogue 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: 08/20/2024
• Initial Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (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