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 twice misidentified enterococcus faecium quality control survey sample, as enterococcus durans in assocaition with the vitek® 2 gp test kit.The customer stated the media used was cps® and cos (columbia sheep blood) and the cards passed their quality control.The test reports were received from the customer.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

A customer reported a misidentification of enterococcus faecium on an eeq survey, as enterococcus durans using the vitek® 2 (v7.01) gp cards.An investigation was conducted.The reference method (sequencing 16s) was performed to determine the intended result.The result was a very good identification to enterococcus faecium 100%, as expected by the eeq survey.Gp cards from the customer lot (2420024123) and a random lot (242398040) were tested using cba and tsab subcultures.The tsab subculture result for the customer lot was a low discrimination between e.Faecium and e.Durans, and the random lot had an excellent identification to e.Faecium (98%).The cba subculture result for the customer lot was a very good identification to the species e.Durans (95%), and the random lot had a very good identification to e.Faecium (93%).The customer result was reproduced with the cba subculture on the customer lot in which a false dman result was observed.The investigation concluded that the strain exhibits an atypical biochemical profile.

• 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: 6326116
• MDR Text Key: 67338963
• Report Number: 1950204-2017-00052
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242383040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2017
• Initial Date FDA Received: 02/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2015
• 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