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

Catalog Number	21347
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• Common Device Name: VITEK® 2 ANC TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; saint louis MO 63042
• MDR Report Key: 7519878
• Report Number: 1950204-2018-00193
• Device Sequence Number: 1385227
• Product Code: JSP
• UDI-Device Identifier: 03573026144364
• UDI-Public: 03573026144364
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2018
• Device Catalogue Number: 21347
• Device Lot Number: 2440399203
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1