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

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) reported to biomérieux a misidentification of a bordetella avium external quality control sample as bordetella hinzii, in association with vitek® 2 gn id test kit.The customer stated the test was performed once and the isolate is not available.A biomérieux investigation will be initiated.

Manufacturer Narrative

An internal investigation was conducted for a misidentification of an aql survey sample #87 of bordetella avium as bordetella hinzi from the vitek® 2 gn card.The strain and raw data were not submitted from the customer.Bordetella avium is not a species claimed by the vitek® 2 gn card.The following limitation is stated in the vitek® 2 product labeling concerning the testing of unclaimed species: "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." the investigation concluded the vitek® 2 gn card performed as intended.

• Brand Name: VITEK® 2 GN ID TEST KIT
• Type of Device: VITEK® 2 GN ID TEST CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; st. louis, MO 63042 ; 3147317301
• MDR Report Key: 6289472
• MDR Text Key: 66148335
• Report Number: 1950204-2017-00035
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: C1, EXEMPT
• 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: 03/20/2017

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: 02/17/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241371840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1