MAUDE Adverse Event Report: BIOMERIEUX, INC. VIRTUO® A UNIT - 411660

Model Number 411660

Device Problems Human-Device Interface Problem (2949); Physical Resistance/Sticking (4012)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

A customer in (b)(6) notified biomérieux of a potential injury to an employee while operating their virtuo® instrument ((b)(4)).The customer reported an employee exacerbated an already existing back problem due to opening and closing the virtuo® door during the manual loading and unloading process.The manual loading and unloading of the instrument occurred for approximately one week while virtuo® robot was not operational.A biomérieux field service engineer (fse) was dispatched to check the door alignment and ensure the door is opening and closing correctly.Upon inspection of the virtuo® unit, the fse found the unit was housed on ¿soft¿ flooring and had settled on the flooring overtime.The settling of the instrument caused the kick stand of the instrument to not move past the vertical position.The customer confirmed the employee did seek medical treatment and was also referred to an occupational health department because of the exacerbated back injury.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

Biomerieux completed an internal investigation following a complaint from a customer site in ireland.The customer claimed one of the users exacerbated a pre-existing back problem as a result of opening and closing the virtuo® door when the robot was not operational.A biomerieux field service engineer (fse) visited the customer site and found the customer¿s virtuo® was installed on ¿soft¿ flooring and had settled on the flooring over time.The settling of the instrument caused the instrument¿s kickstand not to move past the vertical position.The fse performed an instrument adjustment and confirmed the door had returned to normal working condition.Biomerieux reviewed the virtuo® service manual and user documentation.The virtuo® standard laboratory operating environment requirements (sloer) form was reviewed to determine if a floor requirement was specified.The document states the requirement for the customer to provide a vibration-free surface capable of bearing the weight of a fully loaded instrument (level solid surface) for installation.The virtuo® user manual was also reviewed.The virtuo® user manual door opening procedure states the following: "caution: the door latch should be used to pull the door outward.Do not use the sides of the instrument to pull the door of the instrument forward." the root cause of the user¿s exacerbated pre-existing back problem was the settling of the instrument on ¿soft¿ flooring.The instrument was adjusted and confirmed the door had returned to normal working condition.See section h10.

• Brand Name: VIRTUO® A UNIT - 411660
• Type of Device: VIRTUO® A UNIT - 411660
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 9506155
• MDR Text Key: 173173564
• Report Number: 1950204-2019-00328
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• PMA/PMN Number: K161816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 03/06/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1