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

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the organism was subbed and testing included both the customer lot and a random lot of gn cards. Api 20 e was also performed. On all cards tested, a slashline id of shigella group was obtained. Api 20 e, however, identified the organism as e. Coli (99. 8%). Therefore, the final identification is e. Coli. It should be noted that, on laboratory reports giving either shigella or salmonella, an analysis message of "confirm by serological tests" appears. A comparison of card reaction results for salmonella against expected reaction results for e. Coli revealed five (5) atypical negative reactions (bgal, suct, phos, glya, bgur) which led to the misidentification. A comparison of card reaction results for shigella group against expected reaction results for e. Coli revealed six (6) atypical negative reactions (bgal, dmal, suct, phos, glya, bgur) which led to the misidentification. This is an atypical strain.

Event Description

A customer in (b)(6) notified biomérieux of discrepant results associated with vitek® 2 gn test kit (reference 21341) related to misidentification of an organism. The customer reported results from a urine isolate. The organism grew from a pure urine culture at 35 degrees in non-co2 incubator. It was a non-lactose fermenting organism and the vitek® id card identified the organism as salmonella both times. The serology for salmonella was negative and the customer sent the organism to their reference laboratory which identified the organism as e. Coli. The "maldit" of identification was also e. Coli and simple tests showed the following reactions: indole +/-, lactose negative, tsi
=
a/a no h2s. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. There was a delay in the final report until confirmation identification was received from bccdc. An internal biomérieux investigation will be initiated.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; saint louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; saint louis, MO 63042
• MDR Report Key: 6441987
• MDR Text Key: 202002767
• Report Number: 1950204-2017-00100
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: CL 1 EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/24/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241396710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial