VITEK? 2 AST-P652 TEST KIT 421857

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 2020-03-24 for VITEK? 2 AST-P652 TEST KIT 421857 manufactured by Biomerieux Inc..

MAUDE Entry Details

Report Number1950204-2020-00091
MDR Report Key9874414
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-24
Date of Report2020-03-24
Date Mfgr Received2020-02-26
Device Manufacturer Date2019-10-11
Date Added to Maude2020-03-24
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. TENIKA RHODES
Manufacturer Street100 RODOLPHE STREET
Manufacturer CityDURHAM NC 27712
Manufacturer CountryUS
Manufacturer Postal27712
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-P652 TEST KIT
Generic NameVITEK? 2 AST-P652 TEST KIT
Product CodeLON
Date Received2020-03-24
Catalog Number421857
Lot Number8021232403
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
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 2020-03-24

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