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

Model 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
Intended use: 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.Description: a customer in (b)(6) notified biomérieux of experiencing an issue in which a blood culture bottle was left in the customer's virtuo, a unit (ref 411660, serial (b)(4)) for nine (9) days with no result for the bottle (potential false negative).The customer reported that the bottle graph looks like the bottle should be positive for growth and the three (3) other bottles associated with this patient were all positive.Due to the positive results obtained for the other three (3) bottles, there was no delay in reporting results to the treating physician.There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health.An investigation has been initiated.
Additional Manufacturer Narrative
An investigation was initiated in response to a customer complaint of experiencing an issue in which a blood culture bottle was left in the customer's virtuo, a unit (ref 411660, serial (b)(6)) for nine (9) days with no result for the bottle (potential false negative).Investigation queries of manufacturing data do not reveal any adverse trend for the issue.The investigator did not find any adverse trend in the complaint data where a bottle was left loaded on the system past its maximum test time.The instrument log files and data backup were reviewed by the investigator.The root cause of the bottle staying loaded on virtuo with no results could not be determined.A firmware anomaly was documented to improve the system performance around bottles remaining in the instrument past the designated maximum test time.Global customer service recommends to print or view daily load/unload reports and ensure every bottle result is accounted for.For virtuo® instruments connected to myla®, the daily report on myla® should be evaluated for any pending bottle results past their maximum test time.Any discrepancies found on the myla® report should be checked on the virtuo® instrument.The investigator reviewed the user_manual_-_050574-01_-_en_-_2019-08_-_bactalert_virtuo_system_r3.0 and concluded the user manual contains adequate directions and tools (reports) for the user to view and locate bottle records and results.Global customer service will publish "5568-csn bactalert virtuo bottle did not unload" with an optional customer letter to communicate the incident to customer service staff for awareness.

• Brand Name: VIRTUO®, A UNIT
• Common Device Name: VIRTUO®, A UNIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12929108
• Report Number: 1950204-2021-00086
• Device Sequence Number: 5696528
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 03/22/2022

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
• Operator of Device: Health Professional
• Device Model 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: 11/18/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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