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

Catalog Number 21342

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 an enterococcus faecium external quality control sample, as enterococcus faecalis in association with the vitek® 2 gp test kit.The customer performed the test four times and the result was enterococcus faecalis.The customer stated results were not reported to a physician as there was no patient directly associated with the external quality control sample.The test reports were requested from the customer.The isolate is not available.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed.This investigation was initiated due to a misidentification of enterococcus faecium on eeq survey, as enterococcus durans on vitek® (v7.01) gp cards.We performed the reference method to determine the intended result (sequencing 16s) and obtained a very good identification to enterococcus faecium 100% as expected by eeq survey.We tested gp cards with the customer lot (cl: 2420024123) and a random lot (rl: 242398040) on cba and tsab subcultures.Tsab subcultures : we obtained a low discrimination between e.Faecium and e.Durans on the cl and an excellent identification to e.Faecium (98%) on the rl.Cba subcultures : we obtained a very good identification to the species e.Durans (95%) on the cl and a very good identification to e.Faecium (93%) on the rl.We reproduced the customer result only with cba subculture on the cl.We observed a false dman result in this case.The atypical biochemical profile dman(-) may lead to a misidentification on vitek®.Gp cards did not perform as intended on the customer lot.Root cause atypical strain.

• Brand Name: VITEK® 2 GP TEST KIT
• Type of Device: VITEK® 2 GP 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: 6287539
• MDR Text Key: 66130339
• Report Number: 1950204-2017-00034
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K952095
• 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: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242396540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1