MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK® 2 COMPACT

Model Number 27415

Device Problem Application Program Problem (2880)

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

Event Type  malfunction  

Event Description

Intended use: the vitek® 2 system is intended for the automated quantitative or qualitative antimicrobial susceptibility testing of isolated colonies for most clinically significant aerobic gram-negative bacilli, staphylococcus spp., enterococcus spp., streptococcus spp., and yeast.The vitek® 2 system is also intended for the automated identification of most clinically significant anaerobic organisms and corynebacterium species, fermenting and non fermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Issue description: a customer in france notified biomérieux of a specimen result being inaccessible in association with vitek 2 compact 15 (b)(4).Customer reported that they obtained a message: "the isolate could not be found or an error occurred when retrieving it".The pc was restarted twice, but the error was not resolved and result was not accessible.Biomérieux customer service recommended customer to restart analysis of the test; the results were delayed by more than 24 hours.There is no indication or report from the customer that this event led to any adverse event related to the patient's/user's state of health.An investigation has been investigated.

Manufacturer Narrative

Context: ********** a customer in france notified biomérieux of result not accessible in association with vitek 2 compact 15 (ref.27415, serial number: (b)(6).Investigation: *************** batch history record and complaint trend analysis** there is no capa related to the customer¿s complaint recorded.A complaint history review was completed for this issue concluded with no implication of a trend.This complaint has not been identified as a systemic quality issue.Investigation results on october 10th, 2022 a customer in france informed biomérieux about isolate test results were not accessible after the expected incubation and analysis time (in the vitek® 2 systems version 9.02.3 software) and the isolate remained in the preliminary state.The customer reported that when trying to access the test results, the message "the isolate could not be found or an error occurred while retrieving it" appeared and the test results and reports were not able to be viewed or printed.The customer restarted the pc, as instructed, and attempted again to access the results, but the error persisted and the test results were still not accessible.The customer had to set up the card again and resulted in delaying the results by more than 24 hours.The customer system was attempting to deduce the antibiotics cefotaxime (ctx), trimethoprim/sulfamethoxazole (sxt), ofloxacin (ofl) and imipenem (ipm), which are also included as antibiotic tests on the ast-xn05 and ast-n233 cards.When deduced antibiotic mics and actual test result antibiotic mics are attempted to be processed by the advanced expert system¿ (aes), the software is unable to locate a single matching phenotype for multiple test results.In these cases, aes is unable to choose a single match between multiple phenotypes for the same antibiotic result.This results in aes not returning an expected response containing a phenotype match.This results in the isolate remaining in the preliminary (not final) state and a failure to update the isolate state to a final state (to be reviewed, to be approved or approved).No results are saved and thus the results are not displayed.The aes analysis process either returns zero results or returns multiple phenotype results for a single antibiotic, which cannot be processed by the ast analysis process.This results in the isolate remaining in the preliminary (not final) state and the error ¿the isolate could not be found or an error occurred when retrieving it¿ with the results not accessible and not automatically transferred to the configured external communication systems (e.G., the customer¿s laboratory information system, lis).The root cause of the issue is the design of the antimicrobial susceptibility test (ast) analysis engine to handle unexpected responses from the advanced expert system (aes) analysis process when the same antibiotics are indicated both for deduction and also exist as antibiotic tests on the card.Note: the system is operating as initially designed, however, it was indicated the way some customers use the system was determined to be unintended.Conclusion: ************* as a result, biomerieux has taken the action to inquire with the impacted subsidiaries to understand why the customers are configuring ast and aes to deduce antibiotics that are also present as tests on the card(s) and provide that feedback to the vitek 2 program for consideration for product improvement.

• Brand Name: VITEK® 2 COMPACT
• Type of Device: VITEK® 2 COMPACT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: céline lacroix gimon ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15616303
• MDR Text Key: 302570183
• Report Number: 1950204-2022-00034
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 03573026220624
• UDI-Public: 03573026220624
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050002
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• 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