VITEK? 2 AST-YS08 TEST KIT 420739

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-29 for VITEK? 2 AST-YS08 TEST KIT 420739 manufactured by Biomerieux, Inc..

Event Text Entries

[94205247] A customer in (b)(4) reported the occurrence of false susceptible fluconazole and false susceptible flucytosine results for a candida norvegensis eeq strain in association with the vitek? 2 ast-ys08 test kit (ref 420739). Vitek? 2 provided the following results: fluconazole mic = 8 (susceptible), expected result is resistant. Flucytosine mic = 4 (susceptible), expected result is resistant. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient associated with this survey isolate. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1950204-2017-00458
MDR Report Key7067989
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-11-29
Date of Report2018-05-11
Date Mfgr Received2018-04-17
Device Manufacturer Date2017-03-20
Date Added to Maude2017-11-29
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. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, INC.
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal Code63042
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVITEK? 2 AST-YS08 TEST KIT
Generic NameVITEK? 2 AST-YS08 TEST KIT
Product CodeNGZ
Date Received2017-11-29
Catalog Number420739
Lot Number2880297203
Device Expiration Date2018-09-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, INC.
Manufacturer Address595 ANGLUM ROAD HAZELWOOD MO 63042 US 63042


Patients

Patient NumberTreatmentOutcomeDate
10 2017-11-29

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