MAUDE Adverse Event Report: BIOMÉRIEUX, SA ARROW - VITEK MS RP5800 PREP PC CLI

Catalog Number 418883

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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 mould infections.The vitek® ms system is intended for laboratory use by healthcare professionals who are trained in microbiology and good laboratory practices.Issue description: a customer in (b)(6) reported to biomérieux that they have obtained potential misidentification as streptococcus pneumoniae with the product vitek ms rp5800 prep pc cli (ref.418883, serial number (b)(4)).It is understood that there was a misidentification of three samples all as strep.Pneumoniae.At the time of this assessment, the expected result has not been provided by the customer.According to biomérieux¿s local customer service, additional information has been requested regarding the calibration files, mzml data for the samples, the culture conditions.Vitek ms strep.Pneumoniae results: - sample 1: id was 98.5% confidence level.- sample 2: id was 73.4% confidence level.- sample 3: no details for this one - just informed by member of customer staff.Other method: unknown.Expected id: unknown.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.An investigation has been initiated.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint from the united kingdom of obtaining a misidentification as streptococcus pneumoniae with the product vitek ms rp5800 prep pc cli (ref.418883, serial number (b)(6)).Fine tuning.Status good at the time of acquisition.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.Sample data analysis.According to data provided, the misidentification result was obtained from the spectra having medium level of peaks (50 and 62) and a correct score level (-0.17 and -0.01).By reprocessing the customer data with saramis kb v4.17 (ruo), spectra which gave misid results as s.Pneumoniae led to no identification.The strain could be species not present in the vitek ms knowledge bases.Customer has to confirm the identification with reference method (sequencing).The following system limitation is stated in the vitek ms v3.2 knowledge base user manual ref.161150-924 - a: ¿testing of species not found in the database may result in an unidentified result or a misidentification.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.¿.Complementary investigation are needed to find the cause of the misidentification issue.A customer strain return was requested but strains were not available.Consequently, no further investigation could be done and the cause of the issue has been defined as ¿unknown¿.3.Root cause analysis.Unknown (strains were not available for further investigation).4.Corrective or preventive actions: no capa associated.Requested action to lcs.- check sample preparation with the customer.Provide the ¿customer training materials¿ to improve sample spot preparation technique (video, training, ¿ ): global website link: http://go.Biomerieux.Com/gcs-tutorial.- propose vitek® pickmetm (ref 423551/ 423546) to the customer in order to improve the spot quality please watch the tutorial videos for vitek® pickme : http://go.Biomerieux.Com/gcs-tutorial-en (tab vitek® pickme).

• Brand Name: ARROW - VITEK MS RP5800 PREP PC CLI
• Type of Device: ARROW - VITEK MS RP5800 PREP PC CLI
• 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: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 13003664
• MDR Text Key: 288117342
• Report Number: 9615754-2021-00295
• Device Sequence Number: 1
• Product Code: QBN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181412
• 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: 04/26/2022

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 Catalogue Number: 418883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/26/2022
• 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