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 Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from france reported to biomérieux a misidentification of a campylobacter jejuni jejuni strain (atcc 33560 lot 111-38-1) as campylobacter coli in association with the vitek® 2 nh test kit (udi (b)(4)).The customer tested the strain at 24 and 48 hours immediately after incubation.The customer obtained a result of low discrimination and selected campylobacter jejuni jejuni without complementary testing.The second test result was campylobacter coli.The conforming quality control id was eikenella corrodens.There was no patient involvement as the customer was performing a control test for campylobacter strains.A biomérieux internal investigation will be initiated.

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 2450162203): s1 - very good identification to campylobacter coli.S2 - very good identification to campylobacter coli.S3 - very good 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 results 83% 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.

• 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 ; FR ; 3147317301
• MDR Report Key: 6570328
• MDR Text Key: 75417151
• Report Number: 1950204-2017-00155
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2018
• Device Catalogue Number: 21346
• Device Lot Number: 2450162203
• Other Device ID Number: 03573026144357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1