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

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  malfunction  

Manufacturer Narrative

A customer from (b)(6) notified biomerieux of a misidentification of (b)(6) as kingella denitrificans in association with the vitek® 2 nh test kit. An investigation was performed. The reference method (sequencing full 16s) was used to determine the intended result, and gave an excellent identification to the species (b)(6). Vitek® 2 nh cards were tested from the customer lot (cl : 2450075203) and a random lot (rl : 2450061203). Both lots gave an excellent identification to the species (b)(6). The misidentification to kingella denitrificans was not duplicated. A review of the customer's kingella denitrificans data against expected reactions for (b)(6) demonstrated 2 atypical (b)(6) reactions (arga and tyra) and 1 atypical (b)(6) reaction (ellm) according to the nh knowledge base, contributing to the misidentification. An increased number of atypical results can indicate a strain with decreased viability, user set up error or an atypical strain. The increased number of atypical negative reactions may have been caused by leaving the isolate out of co2 for an extended period of time. Since (b)(6) is a fastidious species, it needs to be contained in a co2 environment to retain robustness. If this species is left out on the bench outside of co2 for extended periods, it will become less robust and therefore less reactive in the nh card. The investigation concluded the vitek® 2 nh test kit performed as intended and no further action is required.

Event Description

A customer from (b)(6) notified biomerieux of a misidentification of neisseria gonorrhoeae as kingella denitrificans, when testing a vaginal sample in association with the vitek® 2 nh test kit (udi (b)(4)). The customer reported the isolate was cultured on pvx (polyvitex) media and incubated for 48 hours at 37°c. It was then tested with vitek® 2 nh and the result was kingella denitrificans (99%). The customer stated the strain grew on vcat3 (chocolate agar polyvitex) media and was oxidase positive. The isolate was then tested with an api® nh test strip and the identification was neisseria gonorrhoeae (98. 5%). The customer retested with a subculture after 48 hour incubation and the vitek® 2 nh identified neisseria gonorrhoeae. There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health. A biomérieux internal investigation will be initiated.

• Brand Name: VITEK® 2 NH TEST KIT
• Type of Device: VITEK® 2 NH 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: 6526229
• MDR Text Key: 195993525
• Report Number: 1950204-2017-00131
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K842587
• 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: 07/10/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/09/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450075203
• Other Device ID Number: 03573026144357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial