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 the united states contacted biomérieux to report a misidentification of candida glabrata as candida zellanoides in association with the vitek® 2 yeast (yst) identification (id) test kit.The candida glabrata result was obtained from biofire and morphology plate.The customer indicated they no longer has the patient strains.In addition, the customer was not willing to provide additional details regarding patient symptoms, treatments, outcomes, etc.There was no indication or report from the laboratory that the discrepant result led to any adverse event related to a patient's state of health.Biomérieux investigation will be initiated.
Additional Manufacturer Narrative
A customer in the united states contacted biomérieux to report a misidentification of candida glabrata as candida zellanoides in association with the vitek® 2 yeast (yst) identification (id) test kit.An internal biomérieux investigation was performed.Set up information was not provided by the customer; however, the customer indicated they were also getting low discrimination results and that the instrument was due for preventive maintenance (pm).After pm was completed, the customer reported they were no longer having issues.Two (2) lab reports were submitted that both showed a very good identification of c.Zeylanoides with two (2) atypical positive reactions (2kga, naga) for an identification of c.Glabrata according to the yst knowledge base.An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain.It is possible that the atypical reactions may have been caused by the instrument since the issues resolved after pm.However, without the strain or raw data, it is not possible to further evaluate the cause of the misidentification.Vitek 2 yst lot 2430541203 met final quality control (qc) criteria and passed qc performance testing.

• 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: 7287032
• Report Number: 1950204-2018-00083
• Device Sequence Number: 16601085
• Product Code: JXB
• UDI-Device Identifier: 03573026131937
• UDI-Public: 03573026131937
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2018

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: 05/21/2019
• Device Catalogue Number: 21343
• Device Lot Number: 2430541203
• 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: 01/30/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1