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

Model Number 411660

Device Problem Human-Device Interface Problem (2949)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

A customer in (b)(6) notified biomérieux of a bact/alert® bottle that was not incubated for the correct amount of time on the virtuo® a unit (item# 411660, serial# (b)(4)).The bottle was incubated for five (5) days rather than the expected ten (10) days.The customer indicated that the shortened incubation time of the bottle caused the treating physician to postpone a vascular tissue graft procedure for the patient.At the time of this report, the customer has provided no further details related to the patient condition or if the vascular tissue graft has been completed.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

Biomérieux performed an investigation in response to a customer compliant in which a patient bact/alert® bottle was discharged at five (5) days instead of ten (10) days.The customer changed the maximum test time at the lis to ten days but the bottle was discarded into the waste bin at day five.The issue was confirmed by reviewing the system logs files; however, biomérieux could not duplicate the anomaly during investigational testing at biomérieux.A firmware code review determined the root cause of the incorrect bottle discharge time was due to a virtuo® software/ firmware timing anomaly.Once the bottle data is scanned and identified by the instrument, myla® immediately downloads the bottle message that contains the maximum test time (mtt) change.The maximum test time is transmitted to the virtuo® pc immediately upon identification of the bottle barcode at the virtuo instrument.There are multiple messages sent to the master control board (mcb), about the same bottle, which contain the same bottle id, in a time frame of approximately 1 second.During this influx of information to the mcb, there is potential for the system to misinterpret the mtt change.

• Brand Name: VIRTUO® A UNIT
• Type of Device: VIRTUO® A UNIT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jennifer armstrong ; 595 anglum road; hazelwood, MO 63042 ; 3145068201
• MDR Report Key: 8696145
• MDR Text Key: 147935052
• Report Number: 1950204-2019-00180
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 411660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other