MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT; VITEK® 2 YST ID TEST KIT

Catalog Number	21343
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
During literature review performed by biomérieux, a misidentification result was noted in the article "candida auris: a systemic review and meta-analysis of current updates on an emerging multidrug-resistant pathogen," authored by john osei sekyere.According to the article, vitek® 2 yst id test kit (ref 21343), misidentified candida auris as candida haemulonii and candida duobushaemulonii.It should be noted that c.Auris was not a claimed species until vitek 2 version 8.01 for yst cards.The article also cites articles regarding vitek 2 antifungal testing despite the fact that c.Auris is not claimed on vitek 2 antifungal cards.There is no indication from the article that the discrepant result led to any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
During literature review performed by biomérieux, a misidentification result was noted in the article "candida auris: a systemic review and meta-analysis of current updates on an emerging multidrug-resistant pathogen," authored by john osei sekyere (ghana).According to the article, vitek® 2 yst id test kit (ref 21343), misidentified candida auris as candida haemulonii and candida duobushaemulonii.An internal biomérieux investigation was performed.The article compiled data from 48 publications.No actual lab testing was performed.Specifics concerning test set up and rates of misidentification were not included from the 48 articles.It was noted that the vitek 2 yst id card is the second most widely used identification method.It was noted that there were reports of misidentification of candida auris as candida haemulonii or candida duobushaemulonii, but no specific rates of occurrence were given.It is important to note that candida auris was not claimed by the vitek 2 yst id card until 8.01 software so studies that used earlier software versions would have encountered misidentifications.Without strains, raw data or lab reports, it is not possible to further evaluate the cause of the misidentifications.

• Brand Name: VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT
• Common Device Name: VITEK® 2 YST ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7494115
• Report Number: 1950204-2018-00177
• Device Sequence Number: 1339911
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: GH
• PMA/510(K) Number: C1 EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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 Catalogue Number: 21343
• 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: 04/12/2018
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1