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

Model Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This report was initially submitted following notification that a customer in (b)(6)contacted biomérieux to report a misidentification of campylobacter jejuni ssp jejuni atcc® 33560¿ as campylobacter coli in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit. Investigational testing was performed using two atcc® 33560¿ strains (s1 and s2) submitted by the customer, as well as the internal biomérieux atcc® 33560¿ strain (s3). It should be noted that this atcc® strain is not a qc strain intended for the nh id card. Investigational testing included: vitek® ms: obtained identification to campylobacter jejuni for all three atcc® strains. Vitek® 2 nh id (customer lot 2450185403): s1 - excellent identification to campylobacter coli. S2 - low discrimination between campylobacter coli and c. Jejuni ssp jejuni. S3 - excellent identification to campylobacter coli. Vitek® 2 nh id (random lot 245398920): s1 - excellent identification to campylobacter coli. S2 - low discrimination between c. Coli, c. Jejuni ssp jejuni and c. Fetus ssp fetus. S3 - excellent identification to campylobacter coli. The investigation reproduced the customer result 67% of the time. The investigation concluded campylobacter jejuni ssp jejuni atcc® 33560¿ is an atypical strain for testing via the vitek® 2 nh id card. As previously noted, this atcc® strain is not a qc strain intended for the nh id card.

Event Description

A customer in (b)(6) notified biomérieux of a discrepant result associated with vitek® 2 neisseria-haemophilus identification card (nh) (reference (b)(4)). The customer performed two methods : they used the strain after 24-48 hours of incubation and after 48 hours of incubation. For each incubation, the results of the atcc strain were non-conforming. The result obtained was campylobacter coli instead of campylobacter jejuni. There is no indication or report from the hospital to biomérieux that the discrepant result led to any adverse event related to a patient's state of health. The strain in question is an internal quality control sample. An internal biomérieux investigation will be initiated.

• Brand Name: VITEK® 2 NH TEST CARD
• Type of Device: VITEK® 2 NH TEST CARD,
• 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 ; FR
• MDR Report Key: 6500097
• MDR Text Key: 247108299
• Report Number: 1950204-2017-00122
• 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: 08/31/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/30/2018
• Device Model Number: 21346
• Device Lot Number: 2450185403
• 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: 08/09/2017
• 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: Initial