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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
Description of the problem: a customer in (b)(6) notified biomérieux of experiencing an issue in which the customer found dropped bact/alert® bottles (bottle type, reference not reported) in association with their virtuo® a unit (ref 411660, serial (b)(4)). No result was obtained for one dropped bottle. The customer stated that they found three blood culture bottles on the floor of the virtuo instrument. The customer stated these bottles hadn't been flagged as being dropped. Global customer service (gcs) reviewed the instrument logs. Final gram stain/smear results for each affected bottle, as well as final results of mate bottles, were as follows: all gram stains negative. Mate bottle results: * 210445641an
=
no growth at 48 hrs, * 210445641ae
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no growth at 48 hrs, * 210431854ae
=
no growth at 5 days incubation. Bottle 210431854 unable to provide anaerobic blood culture results; the issue was identified two (2) weeks after loading, leading to delayed result. A history of robotic arm failure was evidenced prior to these errors, which had been previously resolved by field service engineer (fse). No error codes were identified on the day of loading of affected bottles. 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
jeff scanlan
595 anglum road
hazelwood, MO 63042
MDR Report Key12436512
MDR Text Key283315771
Report Number1950204-2021-00074
Device Sequence Number1
Product Code MDB
UDI-Device Identifier03573026369767
UDI-Public03573026369767
Combination Product (y/n)N
Reporter Country CodeUK
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 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/07/2021
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 Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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