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

Catalog Number	21343
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 in (b)(6) notified biomérieux of discrepant results associated with vitek®2 yst test kit (reference 21343).The customer reported misidentification of candida auris on vitek®2 v7.01 system.Customer performed external ring trial for candida.One of the strains should be candida auris, which is not included in the current customer knowledge base.The customer reported getting a 94% result of candida haemulonii on vitek® 2 and 99.9% on vitek® ms.There is no patient associated with this test sample because it was for an external ring trial.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) had notified biomérieux of discrepant results associated with vitek®2 yst test kit (reference 21343).The customer reported a misidentification of candida auris on vitek®2 v7.01 system.The customer reported getting a result of candida haemulonii.An internal biomérieux investigation was performed.Neither the customer's strain nor raw data were available for further evaluation.Candida auris is not a claimed species for the yst card in software version 7.01.When an isolate is tested in the yst card, it will attempt to match the reactions to known reaction patterns stored in the knowledge base.If the reaction pattern of an unclaimed species is tested and matches those in the knowledge base with a high degree of confidence, a misidentification can occur.The vitek 2 product labeling contains the following warning in the limitations section: testing of unclaimed species may result in an unidentified result or a misidentification.Candida auris is available as a claimed species in software version 8.01.Vitek 2 yst test kit, lot # 2430456103 met final qc release criteria.This lot passed qc performance testing.

• Brand Name: VITEK®2 YST TEST KIT
• Common Device Name: VITEK®2 YST TEST KIT
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7330866
• Report Number: 1950204-2018-00099
• Device Sequence Number: 147989
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/12/2018

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: 02/25/2019
• Device Catalogue Number: 21343
• Device Lot Number: 2430456103
• 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: 02/13/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1