MAUDE Adverse Event Report: BIOMERIEUX, INC. BACT/ALERT® VIRTUO® INSTRUMENT

Model Number 411660

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining a "bottle drop" message when testing with the vitruo® instrument.The technician removed a bottle with a cracked bottom that had caused the alert in cell h26.The concerned cell was deactivated, and the instrument was also cleaned.The customer sub-cultured the bottle and obtained a negative result.They reported that no patient treatment was impacted.The technician who removed the bottle was not wearing gloves at the time of removal.His hands touched the liquid on the outside of the bottle.There was no harm from this exposure.The user did not require any medical attention.The customer confirmed that the bottle could have been dropped after the blood collection and before being loaded in the instrument, as they had not checked the condition of the bottle before loading it.

Manufacturer Narrative

A customer in (b)(6) notified biomérieux of operator exposure to the hands while unloading a cracked bottle from the bact/alert® virtuo®.Gloves were not worn while unloading the bottle which caused the liquid from the cracked bottle to come into contact with the operator's hands.Medical attention was not required due to the incident.The root cause was determined to be off-label use/customer error.The operator failed to inspect the bottle prior to loading onto bact/alert® virtuo® instrument.Additionally, the operator was exposed to the contents (blood) of the cracked bottle due to not wearing gloves when unloading the bottle.Biomérieux recommends to reference and follow the bact/alert® virtuo® user manual (514927-1en1) when handling bottles for loading/unloading which states to always wear protective gloves when handling blood, blood components or blood contaminated material.Additionally, all bottles are to be inspected for visible cracks and/or damage prior to loading onto the instrument.

• Brand Name: BACT/ALERT® VIRTUO® INSTRUMENT
• Type of Device: BACT/ALERT® VIRTUO® INSTRUMENT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 8302911
• MDR Text Key: 134977166
• Report Number: 1950204-2019-00039
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 03573026369767
• UDI-Public: 03573026369767
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 04/17/2019

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
• Device Operator: Health Professional
• Device Model Number: 411660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 03/24/2019
• Supplement Dates FDA Received: 04/17/2019
• 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: Initial
• Patient Sequence Number: 1