MAUDE Adverse Event Report: BIOMÉRIEUX SA VITEK MS PRIME - 423281

Model Number 423281

Device Problem Incorrect Measurement (1383)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation was completed in response to this customer complaint of obtaining a misidentification of klebsiella pneumoniae as brucella spp.With the vitek® ms prime (b)(4).Investigation: fine tuning: according to the vilink alert tool criteria, no fine tuning was needed during the tests made on (b)(6) 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 seems to be klebsiella pneumoniae which is present in vitek ms v3.2 kb.Customer data analysis: analysis of mzml sample files shows that identifications are obtained with negative scores (-0.19 and -0.31) which are near the acceptable limit for giving an ¿identification¿ result or a ¿no identification¿ result.This could be explained by a non-optimal spot preparation of the sample strain (culture, spot, different operator) root cause: the causes for the misidentification were determined to be non-optimal spot preparation quality and a knowledge base weakness that leads to misidentifications of poor quality spectra to brucella species.Conclusion: the investigation determined that the misidentification was due to nonoptimal spot preparation and a knowledge base weakness.Local customer service (lcs) has been requested to provide the customer with additional training to help improve the customer's spot preparation technique.Related to the misidentification as brucella these incorrect organism identifications have been seen in conjunction 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.

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 in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.The vitek® ms prime system and this manual are intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.Description: a customer in the united kingdom notified (b)(6) of obtaining a misidentification of klebsiella pneumoniae as brucella spp.With the vitek® ms prime (b)(4).The customer reported that the vitek ms prime obtained a result of brucella spp (98.5%) while the organism was phenotypically not a brucella.The organism grew on maconkey agar within 24 hours, tested oxidase negative, and morphology was long capsulated bacilli.A bruker maldi-tof was used as an alternative identification method and obtained the expected result of klebsiella pneumoniae.The customer indicated that an identification of klebsiella pneumoniae was more in alignment with the other testing and observations.Vitek ms prime: brucella spp.Bruker maldi-tof: klebsiella pneumoniae.There is no indication or report from the customer that this event led to or contributed to death, serious injury, or serious deterioration in the state of health of a patient.

• Brand Name: VITEK MS PRIME - 423281
• Type of Device: VITEK MS PRIME - 423281
• 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: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 16073520
• MDR Text Key: 307258933
• Report Number: 9615754-2022-00152
• Device Sequence Number: 1
• Product Code: QBN
• 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
• Report Date: 12/29/2022

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: 423281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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