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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) contacted biomérieux to report a misidentification of candida auris as candida haemulonii in association with the vitek® 2 yst id test kit.The customer sent the organism strains to a reference laboratory for confirmatory testing via vitek 2; the reference laboratory confirmed the identification to candida haemulonii.The customer also sent the organism strains to a reference laboratory for confirmatory testing via (b)(4); the results were returned as candida auris.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Culture submittal has been requested by biomérieux for internal investigation.Biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in (b)(6) contacted biomérieux to report a misidentification of candida auris as candida haemulonii in association with the vitek® 2 yst id test kit.An internal biomérieux investigation was performed.The customer submitted two (2) isolates and both isolates were subbed, and testing included both yst customer card lots (2430456103, 2430562103) and a random lot, run in duplicate on v08.01 software.Testing on vitek® ms with v3.2 knowledge base was also performed.Isolate 911615 (715526330): for five (5) of the six (6) cards tested, a good id (90%) of c.Haemulonii was obtained.On the remaining card, a low discrimination call of c.Haemulonii/c.Duobushaemulonii was obtained.Vitek ms gave an identification of c.Auris, with a 99.9% confidence value.Isolate 911616 (713793230): on all six (6) cards, a very good or acceptable id of c.Haemulonii was obtained.Vitek ms gave an identification of c.Auris, with a 99.9% confidence value.A comparison of card reaction results for c.Haemulonii against expected reaction results for c.Auris showed three (3) atypical positive reactions (glyla, irhaa, xlta) and two (2) atypical negative reactions (tyra, dmlza) that led to the incorrect call.A comparison of customer card reaction results for the low discrimination results against expected reaction results for c.Auris showed three (3) atypical positive reactions (glyla, irhaa, xlta) and two (2) atypical negative reactions (dgala, dmlza) that led to the incorrect call.An increased number of atypical reactions can indicate contamination, mixed culture, use of non-recommended media, user set up error, or an atypical strain.This issue was determined to involve atypical strains.

• 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: 7388935
• Report Number: 1950204-2018-00125
• Device Sequence Number: 1416976
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: CL. I 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): 08/14/2018

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: 02/25/2019
• Device Catalogue Number: 21343
• Device Lot Number: 2430456103
• 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: 03/11/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1