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) reported a misidentification of a candida norvegensis quality control sample (eeq biology prospective), as candida krusei in association with the vitek® 2 yst test kit (lot 2430385203).The media used was chromid® candida.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) reported a misidentification of a candida norvegensis quality control sample (eeq biology prospective), as candida krusei in association with the vitek® 2 yst test kit (lot 2430385203).An internal biomérieux investigation was performed.The intended identification to c.Norvegensis was confirmed on vitek® ms v3 (knowledge base v3.0).On vitek 2 (v7.01) yst cards, one (1) card of the customer lot (cl : 2430385203) and one (1) card of a random lot (rl : 2430420103) were tested.The results revealed an excellent identification to the species c.Norvegensis on both lots tested and both media.The customer misidentification to candida krusei was not reproduced in-house.A comparison of biochemical profiles between the customer result and the biomérieux testing was performed.Three (3) tests were different: amya, dcela, and esc (esc test is the discriminant test between the two species).In- house, vitek 2 yst test kit performed as intended and no further action is required.

• 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: 7341720
• Report Number: 1950204-2018-00103
• Device Sequence Number: 1221355
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: 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): 05/29/2018

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: 12/16/2018
• Device Catalogue Number: 21343
• Device Lot Number: 2430385203
• 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: 02/06/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1