ADVIA CENTAUR XP AFP N/A 10309980

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 2019-06-04 for ADVIA CENTAUR XP AFP N/A 10309980 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

Report Number1219913-2019-00109
MDR Report Key8666590
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2019-06-04
Date of Report2019-07-26
Date of Event2019-05-03
Date Mfgr Received2019-06-28
Device Manufacturer Date2018-06-26
Date Added to Maude2019-06-04
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 ContactLOUISE MCLAUGHLIN
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal02032
Manufacturer Phone5086604381
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE MA 02032
Manufacturer CountryUS
Manufacturer Postal Code02032
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVIA CENTAUR XP AFP
Generic NameAFP IMMUNOASSAY
Product CodeLOJ
Date Received2019-06-04
Model NumberN/A
Catalog Number10309980
Lot Number73002203
Device Expiration Date2019-09-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-04

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