MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION CARD (ANC) TEST KIT

Catalog Number 21347

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 (b)(6) notified biomérieux of a discrepant result associated with vitek® 2 anaerobic and corynebacteria identification card (anc) test kit.As part of ctcb (centre toulousain pour le contrôle de qualité en biologie) external control 1641, the customer reported the vitek® 2 anc card identified a strain as turicella otitidis instead of rhodococcus equi.The customer obtained results of turicella otitidis at 99%, however, the expected result is rhodococcus equi.Rhodococcus equi is not part of the database for the anc cards.There is a limitation statement in the product information manual that states: "newly described or rare species may not be included in the anc database.Selected species will be added as strains become available.Testing of unclaimed species may result in an unidentified result or a misidentification".However, the vitek 2 obtained an incorrect identification of myroides at turicella otitidis at 99%.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: previous reference testing has identified this isolate as rhodococcus equi.Testing included vitek ® anc cards, one card from two different lots.On vitek® 2, anc card gave with both lots, an unidentified organism.In-house, the misidentification to the species turicella otidis obtained by the customer with discrepant test results : (ure), was not reproduced.Note: rhodococcus equi is out of the gram negative (gn) card knowledge base.There is a limitation on vitek® 2 for species not claimed in the knowledge base: testing of unclaimed species may result in an unidentified result or a misidentification.

• Brand Name: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION CARD (ANC) TEST KIT
• Type of Device: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION CARD (ANC) 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: 6367661
• MDR Text Key: 68610442
• Report Number: 1950204-2017-00074
• Device Sequence Number: 1
• Product Code: JSP
• 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
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2017
• Device Catalogue Number: 21347
• Device Lot Number: 244390210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• 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