MAUDE Adverse Event Report: BIOMÉRIEUX, SA VITEK MS PRIME

Model Number 423281

Device Problem Incorrect Measurement (1383)

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 mold infections.Issue description: a customer in portugal notified biomérieux of a misidentification of escherichia coli as moellerella wisconsensis in association with vitek ms prime ref.(b)(4), lot es00113.Alternate method testing was performed via vitek 2 with results of escherichia coli.Repeat testing was performed on vitek ms prime with results of escherichia coli.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 or any delay in treatment.

Manufacturer Narrative

An investigation was initiated in response to one customer complaint relating to a misidentification of escherichia coli as moellerella wisconsensis.---investigation--- knowledgebase review: the expected identification is unknown because no reference method was used to confirm the expected identification.Fine tuning: according to the vilink alert tool criteria, fine tuning was needed during the tests made on 16 nov 2022 spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator and sample ¿all peaks¿ values were heterogeneous.Customer data review: analysis of mzml sample files shows that the number of "all peaks" are heterogeneous during the issue (31 and 63).Moreover, the misidentification was obtained with a low identification score (-0.26) and a low level of peaks (31) which is at the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result (respectively 30 peaks and -0.4).This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator¿) or a non-optimal fine tuning.The spot providing the misidentification as moellerella wisconsen was very thin.If a spot is too thin, not enough organism have been deposited on the spot.Consequently, the ionization will not be efficient.The amount of ¿all peaks¿ detected during acquisition will be not sufficient for allowing good identification.In addition, analysis of average spectra show that for the spectra f3 giving the misidentification, the number of rejected profile count was 87 versus a number of accepted profile count of 59.In comparison, for the spectra j3 giving the expected identification, the number of rejected profile count was 26 versus a number of accepted profile count of 120.The information highlights that the spectra f3 was not of good quality.Identify and verify root causes: -non optimal spot preparation - fine tuning drifted ---conclusion--- review of customer data indicated non optimal spot preparation and that fine tuning was needed during the impacted tests.Global customer service (gcs) performed a complaint trend analysis and did not identify this issue as a trend.

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.Issue description: a customer in portugal notified biomérieux of a misidentification of escherichia coli as moellerella wisconsensis in association with vitek ms prime (ref.(b)(4), lot es00113).Alternate method testing was performed via vitek 2 with results of escherichia coli.Repeat testing was performed on vitek ms prime with results of escherichia coli.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 or any delay in treatment.

• Brand Name: VITEK MS PRIME
• Type of Device: VITEK MS PRIME
• Manufacturer (Section D): BIOMÉRIEUX, SA; 3, route de port michaud; la balme les grottes 38390 ; FR 38390
• Manufacturer (Section G): BIOMÉRIEUX, SA; 3, route de port michaud; la balme les grottes 38390 ; FR 38390
• Manufacturer Contact: benjamen jost ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15917156
• MDR Text Key: 306108502
• Report Number: 9615754-2022-00143
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K212461
• 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: 01/05/2023

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: 423281
• Device Catalogue Number: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 01/05/2023
• 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