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

Catalog Number	21343
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer from the united states notified biomérieux of a yeast misidentification for a cap survey sample (survey (b)(4) 2018) in association with the vitek® 2 yst test kit (lot # 2430224403).The expected result for this specific cap survey sample, specimen (b)(4), included candida guilliermondii, candida famata/guilliermondii or candida species, not albicans.With initial testing on (b)(6) 2018, vitek 2 obtained a low discrimination result between candida famata / candida guilliermondii as expected.The customer repeated testing on (b)(6) 2018 and obtained a result of candida famata as a single-choice organism.As there is no patient associated with this quality control strain, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
Additional Manufacturer Narrative
A customer from the united states notified biomérieux of a yeast misidentification for a cap survey sample (survey f1-a 2018) in association with the vitek® 2 yst test kit (lot # 2430398203).An investigation was performed.The internal biomerieux cap f1-02 strain was subbed and tested in duplicate on three yst card lots.Api® 20c aux and vitek ms were also performed.911599 (internal survey strain): on three of the six cards tested, a low discrimination call of c.Famata/c.Guilliermondii was obtained.On the remaining three cards, an excellent id of c.Famata was obtained.Api 20c aux gave a very good id (99.7%) of c.Guilliermondii 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.This is an atypical strain.The vitek® 2 yst test kit performed as expected.

• Brand Name: VITEK® 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT
• Common Device Name: VITEK® 2 YST ID TEST KIT
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• MDR Report Key: 7562241
• Report Number: 1950204-2018-00208
• Device Sequence Number: 1134105
• 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: C1 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: 07/08/2018
• Device Catalogue Number: 21343
• Device Lot Number: 2430224403
• 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: 05/07/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 06/01/2018
• 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