MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 COMPACT 60

Model Number 27560

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 nonfermenting gram-negative bacilli, gram-positive organisms, fastidious organisms, and yeasts and yeast-like organisms.Issue description: a customer in colombia notified biomérieux of obtaining delayed results greater than 24 hours while using the product vitek 2 compact 60 (ref.27560, serial number (b)(4)).It was reported that the customer was not able to view the results of a specific isolate due to "error - the isolate could not be found or there was an error when retrieving it" and it does not allow viewing the isolate.The customer was required to set up a new card.As it was reported that customer had to re-sub the organism and then set up a new card, it¿s understood that results were delayed greater than 24 hours.According to biomérieux global customer service (gcs), the customer wasn¿t available to gather the log file as requested.At the time of assessment, the logs have not been provided; gcs needs additional information to be able to confirm if there was an instrument malfunction in this case, because the error can be caused by different issues.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.An investigation will be initiated.

Manufacturer Narrative

Context: a customer in colombia notified biomérieux of obtaining delayed results greater than 24 hours while using the product vitek 2 compact 60 (ref.27560, serial number (b)(6)).Investigation: **batch history record and trend analysis** there is no capa related to the customer's complaint.The global customer service (gcs) review of the 13 month complaint and the trending report from q2 and q3 2022 indicates that there is no trend for the error code in question.Gcs will continue to monitor.Investigation results and conclusion: on 11oct2022 the customer reported that they had an isolate that remained in the qualified state and they obtained an alarm : error "the isolate could not be found or there was an error when retrieving it".It was reported they were unable to view the results which resulted in a > 24 hour delay in reporting the results.No lab reports, logs or data was provided to further evaluate the issue reported in this case.

• Brand Name: VITEK 2 COMPACT 60
• Type of Device: VITEK 2 COMPACT 60
• 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 strauel ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 15682896
• MDR Text Key: 307081177
• Report Number: 1950204-2022-00044
• Device Sequence Number: 1
• Product Code: LON
• UDI-Device Identifier: 03573026136796
• UDI-Public: 03573026136796
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27560
• Device Catalogue Number: 27560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• 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