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 Misdiagnosis (2159)

Event Type  Injury  

Event Description

A customer from the united states reported to biomérieux a misidentification of enterococcus faecalis as granulicatella elegans in association with vitek 2 gp test kit for a blood culture organism.Initial and repeat testing with the vitek 2 gp card gave an identification of granulicatella elegans (98%).Manual testing of the organism resulted in pyr (pyrrolidinyl arylamidase) positive; bile esculin agar negative; and gram stain: gram positive cocci.Per the physician's request, the organism was sent to two separate reference laboratories for susceptibility testing.Both labs identified the organism as enterococcus faecalis by using maldi mass spectrometry.The patient was originally on cephalosporins based on the initial identification.Antibiotics were then changed due to the revised identification of enterococcus faecalis.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

Biomérieux conducted an internal investigation: the submitted isolate was subcultured and gp testing included two cards from the customer's lot (242392110), two cards from a random lot (2420157103) and the api 20 strep kit.All gp cards tested resulted in very good identifications of enterococcus faecalis.The api 20 strep resulted in a very good identification of enterococcus faecalis.Review of the granulicatella elegans data against expected reactions for enterococcus faecalis showed six atypical negative reactions according to the gp knowledge base, contributing to the misidentification.An increased number of atypical negative results can indicate a strain with decreased viability, user set up error or an atypical strain.Vitek 2 gp cards are performing as expected and no further action is required.

• 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: 6213611
• MDR Text Key: 63551501
• Report Number: 1950204-2016-00216
• Device Sequence Number: 1
• Product Code: LQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2017
• Device Catalogue Number: 21342
• Device Lot Number: 242392110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention