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 health professional,user faci report with the FDA on 2018-06-01 for VITEK? 2 YEAST (YST) IDENTIFICATION (ID) TEST KIT 21343 manufactured by Biomerieux, Inc.

Event Text Entries

[110591372] A customer from the united states notified biom? Rieux 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 biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00208
MDR Report Key7562241
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-06-01
Date of Report2018-07-23
Date Mfgr Received2018-06-28
Device Manufacturer Date2017-01-06
Date Added to Maude2018-06-01
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 Received2018-06-01
Catalog Number21343
Lot Number2430224403
Device Expiration Date2018-07-08
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 2018-06-01

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