MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VIRTUO, A UNIT

Catalog Number	411660
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Product description ********************** bact/alert® virtuo¿ microbial detection system is an automated microbial test system capable of incubating, agitating, and continuously monitoring for the detection of aerobic, facultative, and anaerobic microorganism growth from blood and other normally sterile body fluids.Complaint description ************************* a customer in colombia complained after having obtained a false negative result with the virtuo, a unit (ref (b)(4), serial number (b)(6).The customer said that they had inoculated a patient's sample (peritoneal liquid) onto bact/alert fn plus bottle and that after 9 days of incubation the bottle was unloaded as negative.The customer reported that they had inspected the bottle and found that the bottom of the bottle's sensor was yellow, indicating the bottle to be positive therefore they performed a gram stain and had found gram positive cocci.The customer performed identification test that confirmed the microoganism to be s.Epidermidis.No further details were provided the customer states that the concerned patient was not harmed as a consequence of the reported event.
Additional Manufacturer Narrative
Following the false negative result obtained by the customer when using bact/alert® fn plus anaerobic blood culture bottle (lot 0004059210, expiry 07aug2023) an investigation has been carried out at biomérieux manufacturing site.Alarm history file of the customer virtuo system was reviewed.No alarms that would affect bottle processing were present during the time period of incubation of bottle nr232sbb.Instrument log files were reviewed.No instrument events were found that would impact the processing of bottle nr232sbb.The customer reported that the bottle was inoculated with 7 ml of peritoneal fluid, a normally sterile body fluid, and loaded on the instrument without delay.However, the instrument reported the total fill volume as 15 ml of fluid and an image from the bottle within the software confirmed the total fill volume.Data sciences was consulted to review the raw reflectance data (bottle readings).The bottle readings were analyzed and data sciences stated that although the reflectance curve resembles a positive growth curve, the virtuo algorithm functioned as intended and flagged the bottle negative.Based on the reflectance data provided, the organism appeared to be a slow growing one.The bottle was flagged negative because a sustained increase in reflectance over time was not present.The root cause of the issue is attributable to the slow growth of the s.Epidermidis in the bottle.The virtuo algorithm did not detect the rate of reflectance change as indicative of positive bottle.Factors that may have slowed the growth rate include the following: cells and inhibiting factors present in the peritoneal fluid, antimicrobial therapy, or overfilling of the bottle with more than 10 ml of sample.The customer was remindeded to inoculate samples into an aerobic and anaerobic bottle pair and to use the line demarcations on the bottle label to assist in estimating the sample volume and not to exceed the recommended volume of 10 ml.

• Brand Name: VIRTUO, A UNIT
• Common Device Name: VIRTUO, A UNIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO
• Manufacturer Contact: stefania ciranda ; 5, rue des aqueducs; craponne 69290 ; FR 69290
• MDR Report Key: 17397175
• Report Number: 1950204-2023-00010
• Device Sequence Number: 6054121
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 411660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown