ETEST? VORICONAZOLE 532818

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 2016-11-08 for ETEST? VORICONAZOLE 532818 manufactured by Biomerieux, Sa.

Event Text Entries

[59556535] Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[59556536] A customer in (b)(6) reported a discrepant result (out-of-range-low) for candida albicans, atcc? 90028, associated with etest? Voriconazole vo 32 ww f100. The customer had tested two batches of voriconazole in which both gave low results. Customer stated that instead of streaking the plates, they "flow" the plates before they apply the etest?. 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 directly associated with the neqas survey sample. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002769706-2016-00466
MDR Report Key6086722
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2016-11-08
Date of Report2016-10-12
Date Mfgr Received2016-10-12
Device Manufacturer Date2015-06-18
Date Added to Maude2016-11-08
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. ELLEN WELTMER
Manufacturer Street595 ANGLUM ROAD
Manufacturer CityHAZELWOOD MO 63042
Manufacturer CountryUS
Manufacturer Postal63042
Manufacturer Phone3147317301
Manufacturer G1BIOMERIEUX, SA
Manufacturer Street3 ROUTE DE PORT MICHAUD
Manufacturer CityLA BALME LES GROTTES ISERE, 38390
Manufacturer CountryFR
Manufacturer Postal Code38390
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameETEST? VORICONAZOLE
Generic NameETEST? VORICONAZOLE
Product CodeJWY
Date Received2016-11-08
Catalog Number532818
Lot Number1004139440
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMERIEUX, SA
Manufacturer Address3 ROUTE DE PORT MICHAUD LA BALME LES GROTTES ISERE, 38390 FR 38390


Patients

Patient NumberTreatmentOutcomeDate
10 2016-11-08

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