VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2018-05-08 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biomerieux, Inc.

Event Text Entries

[108174362] During literature review performed by biom? Rieux, misidentification results were noted in a study jointly collaborated by assam medical college and hospital and regional medical research center, dibrugarh, assam, india. The results were summarized in the article, "clinically relevant yeast species identified by sequencing the internal transcribed spacer region of r-rna gene and vitek 2 compact (yst card) commercial identification system: experience in a tertiary care hospital in assam, northeast india," authored by reema nath, reeta bora, biswajyoti borkakoty, lahari saikia, and pratap parida. According to the article, vitek? 2 yst id test kit (ref 21343), misidentified the following species as candida famata: meyerozyma guilliermondii, candida albicans, trichosporon asahii, candida parapsilosis, candida tropicalis and wickerhamomyces anomalus. There is no indication from the article that the discrepant results led to any adverse event related to any patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00178
MDR Report Key7495942
Report SourceFOREIGN,LITERATURE
Date Received2018-05-08
Date of Report2018-08-06
Date Mfgr Received2018-07-12
Date Added to Maude2018-05-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. CANDACE MARTIN
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, INC
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityST. LOUIS MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT
Generic NameVITEK? 2 YST ID TEST KIT
Product CodeJXB
Date Received2018-05-08
Catalog Number21343
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC
Manufacturer Address595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-08

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