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

Model Number	411660
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the (b)(6) notified biomérieux of obtaining a false negative instrument result with a positive subculture while testing an ocular fluid sample using the virtuo® instrument (reference # (b)(4), serial # (b)(4)).The customer stated that they received one sample of eye fluid in two blood culture vials and one container.Direct culture of the container was identified as streptococcus agalactiae.The instrument unloaded the bottles as negative, but the bottle sensors were yellow indicating a positive result.The customer subcultured both bottles, which resulted in the growth of gram positive cocci.The bottles were received with less than 1 ml eye fluid, and the customer did not add any supplement or horse blood.Per the product package insert, optimal recovery of isolates will be achieved by adding maximum amounts of specimen.Use of lower volumes may adversely affect recovery and/or detection times of some organisms.In addition, biomérieux recommends that inoculated culture bottles be placed into the bact/alert microbial detection system as soon as possible after collection.If there is an unavoidable delay, inoculated bottles may be maintained at room temperature up to 24 hours before loading into the instrument.Biomérieux support personnel reviewed the virtuo data logs provided by the customer and noticed high reflectivity upon initial load, which supports a delayed entry.It is possible that they already missed the log phase growth of the organism by the time it was loaded into the instrument.More information about a possible delayed entry has been requested from the customer.The streptococcus agalactiae result from the direct culture was reported to the physician.The customer reported that there was no delayed results, no patient harm nor any incorrect treatment due to the false negative instrument result.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in the netherlands regarding a false negative instrument result with a positive subculture while testing an ocular fluid sample using the virtuo® instrument (reference # 411660, serial # (b)(6)).A biomérieux internal investigation has been completed with the following results: biomérieux support personnel reviewed the virtuo data logs provided by the customer.The review showed high reflectance for both bottles ((b)(6)) upon initial load.This is consistent with delayed entry.It is possible that the log phase growth of the organism was missed by the time the bottles were loaded into the instrument.The customer could not account for how the bottles were handled between the time the bottles were inoculated with material ((b)(6) 2020 22:18:24) and when the bottles were loaded on the virtuo instrument ((b)(6) 2020 11:33).The customer stated ¿underside of bottles not viewed before incubation¿.Upon review of the server.Log and error.Log and alarm history files, no errors related to bottle processing were found in the time period of (b)(6) 2020.All events found in the instrument message logs for bottle ids (b)(6) do not indicate an issue with bottle processing.Bottle reading data for (b)(6) were extracted from log files and provided to data science for analysis.Below is a summary of the analysis: (b)(6) ¿ the fa+ bottle reflectance curve does not show an obvious inflection up to indicate a positive test within 5 days.(b)(6) ¿ the fn+ reflectance curve does have a shape that is indicative of a positive test.Noisy data caused interference.The result of data science analysis was shared with firmware engineering.Firmware engineering confirmed the readings had some noise.The noise was not enough to trigger error 10.This error is triggered for a noisy cell in virtuo release 3.The rack that the bottles were loaded in was recommended to be replaced and returned for further analysis.One contributing factor was an operator error of the handling of bottles by the customer prior to loading.The bottles had a 12-hour delay between filling and loading on the virtuo instrument.The customer did not check for color change of the sensor or turbidity of the media prior to loading as recommended in the ifu for delayed entry bottles.It is likely, the logarithmic growth phase of the microorganism occurred prior to loading.The second contributing factor came into play with the anaerobic fn plus bottle, (b)(6).Noisy data interfered with the algorithm determining that the reflectance curve did have a shape that was indicative of a positive test.Despite multiple attempts from customer service, the customer never returned the rack for investigation.The potential root cause of the noisy data cannot be confirmed without the return of the rack.

• Brand Name: VIRTUO A UNIT
• Common Device Name: VIRTUO® A UNIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 10607485
• Report Number: 1950204-2020-00194
• Device Sequence Number: 14064869
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K161816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1