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

Model Number	411661
Medical Device Problem Code	Positioning Problem (3009)
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 a bottle placement failure in association with the virtuo®, b unit ( reference 411661 serial (b)(4)).The misplaced bottle had flagged positive, but was not unloaded to the chute.Instead, the customer reported that it dropped inside of the instrument.The customer confirmed the bottle flagged positive on the afternoon of (b)(6) 2019, but it was not found until the following monday morning on (b)(6) 2019.It should be noted that the instrument would have alerted the customer with error 7 "bottle dropped." no report was made by the customer of obtaining an error message.The customer reported that there was no patient harm or delayed treatment due to the dropped bottle.The customer reported a delay of greater than 8 hours in reporting results.Biomérieux will initiate an internal investigation.
Additional Manufacturer Narrative
A customer in (b)(6) notified biomérieux of a bottle placement failure in association with the virtuo®, b unit ( reference 411661 serial (b)(4)).The misplaced bottle had flagged positive, but was not unloaded to the chute.Instead, the customer reported that it dropped inside of the instrument.The customer confirmed the bottle flagged positive on the afternoon of(b)(6) 2019, but it was not found until the following monday (b)(6) 2019.Biomérieux investigation was conducted.A bact/alert® bottle that flagged positive around 5:00am sunday morning (b)(6) 2019, was not deposited into the bottle return area chute.A bottle that is positive is normally deposited into the chute for retrieval.The bottle was found inside the instrument sometime monday afternoon (b)(6) 2019.Potential impact of the deficiency could be a "delayed result".Note that when a bottle is flagged positive, the result is recorded and available from the positive bottle list on bact/alert® virtuo® regardless of whether the bottle was placed in the chute.The customer indicated that patient health was not compromised nor impacted.Results were delayed > 8 hours.Diagnostic data on the bact/alert® virtuo® instrument was unavailable before the issue was reported by the user to biomerieux.When the field service engineer attempted to retrieve the diagnostic logs, dlogs and instrument message logs, the logs had already aged off the system.Backup data can only remain on the system for approximately four (4) weeks.The issue occurred on 24feb2019, however, the customer notified biomérieux on 31mar2019.Due to the dlogs or instrument message logs no longer available for retrieval or evaluation, biomérieux cannot investigate this issue any further.The system is designed to mitigate the risk of delayed results from dropped bottles, and notifies the user of: 1) result (positive/negative) of the bottle under test 2) a dropped bottle that did not make it to the chute via error message "error 7 - bottle dropped".As diagnostic data was not provided or available, it is not possible to isolate the root cause.

• Brand Name: VIRTUO® B UNIT
• Common Device Name: VIRTUO® B UNIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 8566666
• Report Number: 1950204-2019-00114
• Device Sequence Number: 11518218
• Product Code: MDB
• UDI-Device Identifier: 03573026369774
• UDI-Public: 03573026369774
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/11/2019

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: 03/31/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1