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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VIRTUO, A UNIT

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BIOMÉRIEUX, INC. VIRTUO, A UNIT Back to Search Results
Model Number 411660
Device Problem Failure to Obtain Sample (2533)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Issue description: a customer in (b)(6) notified biomérieux of experiencing an issue in which a positive bact/alert® bottle (reference not provided) was reported to be lost in their virtuo® a unit (ref. 411660, serial (b)(4)). Delayed result (>8 hours) was obtained for one ¿missing bottle¿. The customer stated that they had an issue regarding a "missing bottle". Biomérieux¿s fse (field system engineer) visited the customer site and identified that they had a connection issue due to the firewall and also a robot jam during calibration. The firewall and connection issues were resolved, but bottles had gotten stuck in racks so the racks had to be disabled. The fse resolved the issue with the racks so the instrument could be fully used again with all racks enabled. The issue with the "missing bottle" caused a delay in reporting result of a positive bottle. It was reported that there was blood culture result delayed more than 8 hours to the physician. The customer also reported that the users of the instruments may have been exposed to blood due to broken bottles. It was reported that four (4) bottles were analyzed. The three (3) that were not broken gave a negative result. In the end the bottle was found in the correct cell (m7), and was broken in the bottom. The customer stated that the bottle could not be found in m7 while it was missing. Biomérieux will initiate an internal investigation. There is no indication or report from the customer that this event led to any adverse event related to the patient's state of health. An investigation has been initiated.
 
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Brand NameVIRTUO, A UNIT
Type of DeviceVIRTUO, A UNIT
Manufacturer (Section D)
BIOMÉRIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer (Section G)
BIOMÉRIEUX, INC.
595 anglum road
hazelwood MO 63042
Manufacturer Contact
céline strauel
5, rue des aqueducs
craponne 69290
FR   69290
MDR Report Key13575784
MDR Text Key287329486
Report Number1950204-2022-00004
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026369767
UDI-Public03573026369767
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K161816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number411660
Device Catalogue Number411660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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