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 from the united stated reported a misidentification of a candida tropicalis cap survey sample (f-01 fa 2018) as candida parapsilosis in association with the vitek® 2 yst test kit.The tested was repeated three times and the result was candida parapsilosis twice at 93% and once at 95%.Biomérieux requested the survey and test reports from the customer.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer from the united stated had reported a misidentification of a candida tropicalis cap survey sample (f-01 fa 2018) as candida parapsilosis in association with the vitek® 2 yst test kit.An internal biomérieux investigation was performed using the internal sample of the strain.The internal biomérieux cap f-01 strain was rehydrated, subcultured to sda-emmons agar and incubated for 18-24 hours, 35-37° c, aerobically without co2.A second subculture was performed, and testing included individual organism suspensions with the yst cards from four (4) different card lots, in duplicate, as well as the vitek ms.The vitek 2 yst card lots tested included three customer lots (2430398223, 2430432203, 2430224403) and a random lot (2430603203).For the eight (8) yst cards, five (5) resulted in very good identifications of c.Tropicalis, two (2) gave a low discrimination identification of c.Famata/c.Tropicalis, and the remaining card gave a low discrimination identification c.Famata/parapsilosis/tropicalis.The vitek ms resulted in an identification of c.Tropicalis with a 99.9% confidence value.The customer's misidentification was not reproduced.The low discrimination identifications including c.Tropicalis are considered correct.Therefore, the vitek 2 cards are performing as expected.

• 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: 7542396
• Report Number: 1950204-2018-00198
• Device Sequence Number: 19441794
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2018

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: 12/29/2018
• Device Catalogue Number: 21343
• Device Lot Number: 2430398223
• 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: 05/01/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1