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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GN TEST KIT

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BIOMERIEUX, INC VITEK® 2 GN TEST KIT Back to Search Results
Model Number 21341
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in france notified biomérieux of discrepant results associated with vitek® 2 gn test kit ((b)(4)) related to misidentification of pseudomonas aeruginosa and brevundimonas diminuta instead of rhodococcus equi. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
A customer in (b)(6) notified biomérieux of a misidentified rhodococcus equi as pseudomonas aeruginosa and brevundimonas diminuta for an eeq survey sample in association with vitek® 2 gn test kit (udi (b)(4)). An investigation was performed. Previous reference testing has identified this isolate as rhodococcus equi. Rhodococcus equi is out of the gn card knowledge base. There is a limitation on vitek® 2 for species not claimed in the knowledge base. Newly described or rare species may not be included in the gn database. Selected species will be added as strains become available. Testing of unclaimed species may result in an unidentified result or a misidentification.
 
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Brand NameVITEK® 2 GN TEST KIT
Type of DeviceVITEK® 2 GN TEST KIT
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 63042
MDR Report Key6388983
MDR Text Key69560543
Report Number1950204-2017-00084
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K910666
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/13/2017
Device Model Number21341
Device Lot Number241389540
Other Device ID Number03573026131913
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 Received04/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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