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

Catalog Number 21347

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of misidentification results when testing the clostridium sporogenes atcc® 11437¿ strain with vitek® 2 anc id test kit (reference 21347).The customer reported testing the isolate three (3) times with the following methods and results: 1- using tsa media and after 24 hours of incubation in anaerobic atmosphere , the customer obtained an identification of slashline (mixed) clostridium group.2- using cba media and after 24 hours of incubation, still in in anaerobic atmosphere, the customer obtained the same result as slashline clostridium group.3- using cba media (that is a recommended media for vitek® 2) and after 48 hours of incubation, the customer obtained a low discrimination for clostridium group.The customer reported using an isolated organism from the media where he observed single colonies.This same atcc strain has been identified with the maldi system as c.Sporogenes species.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.To be noted, as specified in the instructions for use (ref.043907-02), the impacted atcc 11437 c.Sporogenes strain is not recommended for anc cards.Also the instructions for use (ifu) state the following "certain species may belong to a slashline (mixed) taxa identification.This occurs when the biopattern is the same for the taxa listed.Supplemental tests may be used to separate slashline taxa." however, vitek 2 provided low discrimination results that did not include clostridium sporogenes.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This investigation was initiated due to a customer report of low discrimination results with qc strain clostridium sporogenes atcc 11437 with the vitek® 2 anc test kit, v7.01 software.This is not a biomérieux recommended strain for anc quality control.There was no return of the customer strain for investigation; therefore, only the internal reference strain was tested (api# 0801026).On vitek 2 (v7.01) anc cards, one card of customer lot (cl : 2440399203) and one card of random lot (rl : 2440470403) were tested from cos subculture with anaerobic environment.These tests gave an excellent identification to clostridium sporogenes (99%) on both lots tested.Conclusion: the expected identification to clostridium sporogenes was obtained with the internal reference strain (no return of the customer strain).The customer result is not reproduced in-house.

• Brand Name: VITEK® 2 ANC TEST KIT
• Type of Device: VITEK® 2 ANC 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: candace martin ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 7519878
• MDR Text Key: 109368487
• Report Number: 1950204-2018-00193
• Device Sequence Number: 1
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440399203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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