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

Catalog Number	21343
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in the united states notified biomérieux of a misidentification of cap survey strain candida tropicalis in association with the vitek® 2 yeast (yst) identification (id) test kit.The vitek 2 yst id card identified the strain to candida parapsilosis.Following receipt of the cap answer, the customer retested the original cap strain via yst id card; obtained results of candida lusitaniae and candida haemulonii.Testing of a second specimen from cap provided an organism identification to the expected result of candida tropicalis.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any person's state of health, as there is no patient associated with the cap survey strain, biomérieux requested strain submittal from the customer.A biomérieux internal investigation has been initiated.
Additional Manufacturer Narrative
A customer in the united states had notified biomérieux of the misidentification of cap survey strain candida tropicalis in association with the vitek® 2 yeast (yst) identification (id) test kit.The vitek 2 yst id card identified the strain as candida parapsilosis.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 YEAST (YST) IDENTIFICATION (ID) TEST KIT
• Common Device Name: VITEK® 2 YST ID CARD
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• MDR Report Key: 7591900
• Report Number: 1950204-2018-00222
• Device Sequence Number: 2144033
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: CL. I 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: 02/01/2019
• Device Catalogue Number: 21343
• Device Lot Number: 2430432203
• 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: 05/21/2018
• Supplement Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 06/12/2018
• 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