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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC. VIRTUO® A UNIT Back to Search Results
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.
 
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Brand NameVIRTUO® A UNIT
Type of DeviceVIRTUO® 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 Key8696145
MDR Text Key147935052
Report Number1950204-2019-00180
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026369767
UDI-Public03573026369767
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K161816
Number of Events Reported1
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 Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number411660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/24/2019
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 Unkown

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
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