MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 NH ID TEST KIT

Catalog Number 21346

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of a misidentification result for an atcc campylobacter fetus strain when using vitek® 2 nh id test kit (ref 21346), lot 245385020.Vitek® 2 identified the strain as campylobacter coli twice.The customer retested this atcc strain with the maldi-tof method and obtained camylobacter fetus.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health.There was no patient associated with this atcc quality strain.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal biomérieux investigation was performed with results as follows: the submitted isolate was subcultured and incubated in microaerophilic conditions at 42°c.The two (2) lots tested by the customer have both expired so testing included individual organism suspensions on nh cards from two (2) random lots in duplicate and vitek® ms.A total of four (4) nh cards were tested initially, three (3) resulting in very good identifications of neisseria cinerea and the remaining card resulted in a low discrimination identification of campylobacter coli/n cinerea.The investigation was repeated and for the four nh cards tested, two (2) resulted in very good identifications of neisseria cinerea, one (1) low discrimination identification of campylobacter fetus/c.Coli and one unidentified organism.The vitek® ms resulted in the expected identification of campylobacter fetus ssp fetus with a 99.9 % confidence value.A review of the customer's data against expected reactions for identification of campylobacter fetus demonstrated one atypical positive reaction (iglm) and one (1) atypical negative reaction (dmlt) according to the nh knowledge base contributing to the misidentifications.An increased number of atypical results can indicate a strain with decreased viability, user set up error or an atypical strain.This is an atypical strain.It should be noted that this atcc strain is not a recommended qc strain for the vitek® 2 nh card.

• Brand Name: VITEK® 2 NH ID TEST KIT
• Type of Device: VITEK® 2 NH ID 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: 6866880
• MDR Text Key: 87240039
• Report Number: 1950204-2017-00304
• Device Sequence Number: 1
• Product Code: JST
• UDI-Device Identifier: 03573026144357
• UDI-Public: 03573026144357
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: C1 EXEMPT
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2017
• Device Catalogue Number: 21346
• Device Lot Number: 245385020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/14/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• 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