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 the united states reported to biomérieux a misidentification of an external quality control (cap) survey sample of enterococcus gallinarum, as enterococcus casseliflavus in association with vitek® 2 gp test kit.Repeat testing resulted in the same misidentification.The customer reported the organism was subcultured 3 times before testing.The test report and isolate was requested from the customer.An internal biomérieux investigation will be initiated.

Manufacturer Narrative

A biomérieux internal investigation was conducted for a misidentification of an external quality control (cap) survey isolate of enterococcus gallinarum with the vitek® 2 gp card lot 2420050103.This isolate was not submitted to biomérieux so the internal lyophilized cap sample was reconstituted and tested.The reconstituted sample was subcultured and gp testing included two cards each from four of the implicated customer lots and two cards from a random lot.The api 20 strep test was also performed although it does not identify e.Casseliflavus or e.Gallinarum without supplemental testing.Nine of the ten gp cards tested resulted in low discrimination of e.Casseliflavus/e.Gallinarum.Vitek® 2 proposed additional testing to separate these species.The isolate did not demonstrate yellow pigmentation and tested hip positive on the api test kit, resulting in an identification of e.Gallinarum.The remaining card gave an excellent identifications of e.Gallinarum.Review of the e.Casseliflavus customer data against expected reactions for e.Gallinarum demonstrated two atypical negative reactions (adh1, cdex) and one atypical positive reaction (pul), contributing to the misidentification.The customer data shows the isolate exhibited atypical growth behavior.The investigation concluded the vitek 2® gp id test kit is performing as intended.

• 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: 6243504
• MDR Text Key: 64617741
• Report Number: 1950204-2017-00010
• 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: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2018
• Device Catalogue Number: 21342
• Device Lot Number: 2420050103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• 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