VITEK? 2 YST 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 2018-05-31 for VITEK? 2 YST TEST KIT 21343 manufactured by Biomerieux Inc..

Event Text Entries

[110344662] A customer in the united states reported a misidentification of a candida guilliermondii cap survey sample (f1-02), as candida famata in association with the vitek? 2 yst test kit. The customer reported candida famata as their identification. Repeat testing gave a result of low discrimination between c. Guillermondii and c. Famata. The customer submitted the lab and the cap survey reports for evaluation. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2018-00201
MDR Report Key7558261
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-05-31
Date of Report2018-07-10
Date Mfgr Received2018-06-12
Device Manufacturer Date2018-01-07
Date Added to Maude2018-05-31
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 ContactMS. DEBRA BROYLES
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 YST TEST KIT
Generic NameVITEK? 2 YST TEST KIT
Product CodeJXB
Date Received2018-05-31
Catalog Number21343
Lot Number2430590203
Device Expiration Date2019-07-09
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 2018-05-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.