MAUDE Adverse Event Report: BIOMÉRIEUX, SA. VITEK MS PRIME

Model Number 423281

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Intended use: vitek® ms prime 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 prime system is a qualitative in vitro diagnostic device indicated for use inconjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.Issue description: a customer in the united kingdom notified biomérieux of misidentification as brucella species when using vitek ms prime instrument (ref.423281, serial number: (b)(4).Customer indicated that during the last week, they received two (2) identifications as brucella with 80% and 99% of confidence but neither isolate was actually brucella.Customer indicated that two members of the staff were prescribed prophylactic antibiotics until they had the specialist lab results back to be sure of the correct identification.Biomérieux customer service indicated that a customer communication was previously issued to inform customers about potential misidentification as brucella spp with vitek ms kb3.2.Thus far, reported incorrect organism identifications have been related to degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue will be resolved with the next vitek ms kb v3.3.At the time of assessment, there was no indication or report from the customer that this event led to any adverse event related to any patient's state of health.Two users were prescribed prophylactic antibiotics since they were presumed to have been potentially exposed to brucella.An investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of misidentification as brucella species when using vitek ms prime instrument (ref.: 423281, serial number : (b)(6)).Investigation.Complaint trend analysis: global customer service (gcs) performed a complaint trend analysis for the period from august 2022 to october 2022 and did not identify the customer's issue as a trend for the vitek ms prime.Fine tuning: according to the vilink alert tool criteria, no fine tuning was needed during the tests made on 26 oct 2022.Spot preparation quality: the customer¿s spot preparation quality was not optimal.The calibrator ¿all peaks¿ values were heterogeneous.Knowledge base (kb) review: the expected identification is unknown because no reference method was used to confirm the expected identification.Customer data analysis: analysis of sample files shows that spectra c3 and c4 were very different.However, the overall spectrum profiles were similar.More detailed spectrum analysis shows mass shift between the two spectra.Consequently, masses could be affected in a wrong ¿bin¿ and then it could lead to a misidentification.Based on these findings, the issue could be explained by a non-optimal spot preparation of this sample strain.Root cause: the investigation determined the likely cause to be non-optimal spot preparation.Related to the spot picture, the deposit seems to be thin.Conclusion.The misidentification is likely due to non-optimal spot preparation quality.Local customer service (lcs) has been requested to provide the customer with additional training materials to help improve spot preparation technique.Related to the misidentification as brucella, the incorrect organism identifications are associated with degraded spectra (linked to a non-optimal spot preparation or a non-optimal fine-tuning).This issue will be fixed with the next vitek ms kb v3.3.

• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 15753383
• MDR Text Key: 303251206
• Report Number: 9615754-2022-00123
• Device Sequence Number: 1
• Product Code: QBN
• UDI-Device Identifier: 03573026611422
• UDI-Public: 03573026611422
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/27/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/24/2022
• Supplement Dates FDA Received: 12/05/2022
• 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
• Patient Outcome(s): Required Intervention