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

Model Number	411661
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) notified biomérieux of experiencing a dropped bottle error in which the culture bottle was not fully seated in a cell and led to a delay in reporting results 24 hours, in association with their virtuo® b unit ref 411661, serial (b)(4).The bottle was incubated and agitated correctly but the growth was not monitored by the virtuo.The issue was identified while the customer was attempting to perform cell calibrations.Local customer service (lcs) reviewed the calibration logs and found that the calibration for cell l23 had failed.Lcs asked the customer to see if the cell was empty.The customer found that the bottle was in the cell and was approximately 1cm from being fully inserted into the cell.As recommended by lcs, the customer subcultured the bottle that was found still in the cell and no growth was observed.Negative results were also obtained for the partner bottles in the virtuo.The customer confirmed that there was no impact to the patient treatment due to the delay in reporting results.A field service engineer (fse) visited the customer's site and performed an inspection on the instrument.The fse found that cell l23 had an obstruction which appeared to be hot melt glue and removed this obstruction.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
This report was initially submitted following notification from a customer in denmark regarding a dropped bottle error in which the culture bottle was not fully seated in a cell and led to a delay in reporting results >24 hours, in association with their virtuo® b unit (ref 411661, serial (b)(6)).The bottle was incubated and agitated correctly but the growth was not monitored by the virtuo.The issue was identified while the customer was attempting to perform cell calibrations.Local customer service (lcs) reviewed the calibration logs and found that the calibration for cell l23 had failed.Bottle nrws0krg was left unattended for 2.5 days.A field service engineer (fse) visited the site and visually examined the cell.The fse found a piece of debris stuck to the side of the cell which had likely caused the bottle to become stuck in the cell.The primary root cause of this issue was a piece of debris lodged onto the wall of cell l23 causing the bottle to become stuck before it reached the bottom of the cell.This led to the occurrence of the (7) bottle dropped messages.The instrument functioned as expected when the bottle was not correctly placed in the cell.An additional root cause of the bottle being left in the instrument is that the customer did not follow the "alarm causes and resolutions" in the virtuo user manual trouble shooting section.The section advises the customer to check for cells containing an unseated bottle.The same section also advises the user: ¿if no bottle or calibration standard was found, then it is possible that it was placed in a cell, but was not seated well enough to be detected by the instrument.¿ a warning to the user is also provided stating, ¿(warning box): the consequences of not following instructions to resolve a 'dropped bottle' alarm may be no test results.¿.

• Brand Name: VIRTUO B UNIT
• Common Device Name: VIRTUO® B UNIT
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 11066450
• Report Number: 1950204-2020-00220
• Device Sequence Number: 14513475
• Product Code: MDB
• UDI-Device Identifier: 03573026369774
• UDI-Public: 03573026369774
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 02/18/2021

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: 411661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1