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

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.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 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 Key: 6388983
• MDR Text Key: 69560543
• Report Number: 1950204-2017-00084
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2017
• Device Model Number: 21341
• Device Lot Number: 241389540
• Other Device ID Number: 03573026131913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• 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
• Patient Sequence Number: 1