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 (b)(4)).The customer reported that the rhodotorula spp is not related phylogenetically with the cryptococcus, and instead of a mistaken identification as other cryptococcus sp, vitek® 2 gave a result of rhodotorula as tested identification, and somehow gave alternative possibility of cryptococcus albidus in the analysis message.The percentage identification of (b)(6)% is low, and (b)(6) ink does not differentiate these organism as both shown encapsulated budding yeast cell.The sample used was for quality assurance testing.There was no effect on patient treatment or condition.An internal biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) obtained an identification of rhodotorula glutinis/mucilaginosa/ (crypto.Laurentii) using the vitek® 2 yst test kit for a rcpa survey strain.The expected identification was cryptococcus (naganishia) antarticus or c.Bhutanensis.An internal biomérieux investigation was performed; however, the customer's strain and raw data were not available for submission.Neither c.Antarticus nor c.Bhutanensis are in the vitek 2 yst card knowledge base.When an isolate is tested using the vitek 2 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 match 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.Vitek 2 yst test kit (lot # 2430352103) met final qc release criteria and passed initial 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: 7317244
• Report Number: 1950204-2018-00091
• Device Sequence Number: 16170497
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: CI EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2018

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: 11/13/2018
• Device Catalogue Number: 21343
• Device Lot Number: 2430352103
• 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: 02/08/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 06/08/2018
• Patient Sequence Number: 1