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 guilliermondi in association with the vitek® 2 yeast (yst) identification (id) test kit.The vitek 2 yst id card identified the strain to candida famata.Repeat test obtained the same result.The customer submitted the identification of candida famata to cap.Cap indicated the result to be incorrect; candida guilliermondi was the expected result.The customer stated they plate the direct specimen, sub-culture it once, then test on the vitek 2 system according to cap instructions.Following receipt of the cap answer, the customer performed testing on the cap strain via vitek ms, and obtained the expected result of candida guilliermondi.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 notified biomérieux of a misidentification of a candida guilliermondii cap survey strain (f1-02 2018) as candida famatan in association with the vitek® 2 yeast (yst) identification (id) test kit.An investigation was performed.The expected identification is candida guilliermondii, but the customer obtained an excellent identification of c.Famata on yst lot 2430167403.When tested again on a second lot (2430364203), a low discrimination result of c.Famata/c.Guilliermondii was obtained.The customer reported c.Famata to cap.It should be noted that both c.Guilliermondii and c.Famata/c.Guilliermondii were acceptable answers; however, c.Famata alone was not.Both the customer submitted strain and the internal cap survey strain were subbed and tested on the customer lot 2430364203 (2430167403 has since expired) and a random lot of yst cards, in duplicate.Api 20c aux and vitek ms were also performed.911606 (customer submitted strain): on all four cards tested, an excellent identification of c.Famata was obtained.Api 20c aux gave a very good id (99.7%) of c.Guilliermondii and vitek ms gave an identification of c.Guilliermondii, with a 99.9% confidence level.911599 (internal survey strain): on one of the customer lot cards and one of the random lot cards, a low discrimination call of c.Famata/c.Guilliermondii was obtained.On one of the customer lot cards and one of the random lot cards, an excellent id of c.Famata was obtained.Api 20c aux gave a very good id (99.7%) of c.Guilliermondii and vitek ms gave an identification of c.Guilliermondii, with a 99.9% confidence level.A comparison of card reaction results for c.Famata against expected reaction results for c.Guilliermondii revealed one atypical negative reaction (dgata) that led to the incorrect call.The investigation concluded that this is an atypical strain.The vitek 2 yst card performed as intended.

• 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: 7590866
• Report Number: 1950204-2018-00221
• Device Sequence Number: 2018696
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/23/2018

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: 05/12/2018
• Device Catalogue Number: 21343
• Device Lot Number: 2430167403
• 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: 05/20/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/12/2018
• Supplement Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1