• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMÉRIEUX, INC. VIRTUO, A UNIT 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
A customer in (b)(6) notified biomérieux of experiencing an issue in which the customer found a dropped bact/alert® bpn bottle in association with their virtuo® a unit (ref 411660, serial (b)(4)). No result was obtained for the dropped bottle. The customer stated that the bottle was found at the bottom of one of their virtuo modules. According to the customer, the bottle was loaded on (b)(6) 2021 and there was a robot jam error that occurred around the time this bottle was loaded. Global customer service (gcs) reviewed the instrument logs. Gcs searched and could not find the bottle in question, (b)(4). Gcs did locate information in the audit trail for the mate bottle, patrdw74. The mate bottle was loaded on (instrument 4) spc bank2-b1 [serial # (b)(4)). The error logs showed no jams or adverse events during the incubation period of the bottle for instrument (b)(4). The instrument in which the mate bottle was loaded did have a jam but not a "dropped bottle" alarm. The instrument constantly monitors the status of where bottles reside in the instrument. In the event a bottle did not make it to its destination there would be an associated dropped bottle alarm. This was not witnessed on either instrument. Gcs has not identified any evidence from the logs that the bottle in question was actually loaded by the instrument, and it is possible that the user dropped the bottle inside the instrument. Additional information has been requested from the customer. 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. A biomérieux internal investigation will be initiated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIRTUO, A UNIT
Type of DeviceVIRTUO®, A UNIT
Manufacturer (Section D)
BIOMÉRIEUX, INC.
595 anglum road
hazelwood MO 63042
MDR Report Key12238688
MDR Text Key282122080
Report Number1950204-2021-00048
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026369767
UDI-Public03573026369767
Combination Product (y/n)N
PMA/PMN Number
K161816
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number411660
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Is This a Reprocessed and Reused Single-Use Device? No

-
-