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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer in (b)(6) reported a misidentification of a candida auris strain from a patient's ear swab, as candida duobushemulonii, in association with the vitek® 2 yst test kit (lot 2430316403).The customer reported that the patient isolate was initially identified correctly as c.Auris (90%) with the yst card.However, repeat testing with the yst card identified candida duobushemulonii.The bruker id obtained identification of c.Auris but with a bad score in research use only mode.The control strain ((b)(4)) also misidentified as c.Duobushemulonii.The customer stated that the strains were tested on two different instruments, with two different lots.The media used for the first testing was pvx (chocolate agar + polyvitex) and was used after 24h co2 35°c.The retesting was done from chromid® candida after 48h 35°c and 72h 35°c.The customer reported that patient results and treatment were not impacted.There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
An internal biomérieux investigation was performed due to a misidentification of two (2) strains of candida auris with vitek® 2 v8.01 yst card.Two strains (#104245 called s1 and cbs #10913 called s2) were received at biomérieux.The identification to candida auris was confirmed on vitek® ms v3 (knowledge base v3.2) for the two (2) submitted strains.On vitek 2 (v8.01) yst card, two (2) cards of customer lots (cl1: 2430316403 and cl2: 2430518203) and one (1) card of random lot (rl: 2430385203) were tested from chromid® candida (can2 biomerieux) subculture for each strain.These tests gave: strain 1 = very good or good identification to candida duobushaemulonii on the three (3) lots tested.Strain 2 = excellent identification to candida duobushaemulonii on the three (3) lots tested.The misidentification obtained by the customer was duplicated.A review of the customer's candida duobushaemulonii reactions demonstrated two (2) atypical negative reactions (tyra , naga) for an identification of candida auris according to yst knowledge base.A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend.The most recent quarterly trend review did not identify this complaint as a systemic quality issue.

• 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: 7466564
• Report Number: 1950204-2018-00163
• Device Sequence Number: 13492777
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 08/28/2018

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: 10/08/2018
• Device Catalogue Number: 21343
• Device Lot Number: 2430316403
• 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: 04/04/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1