ADVIA CENTAUR XPT CA 15-3 N/A 10327620

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 2020-03-31 for ADVIA CENTAUR XPT CA 15-3 N/A 10327620 manufactured by Siemens Healthcare Diagnostics, Inc..

MAUDE Entry Details

Report Number1219913-2020-00095
MDR Report Key9908170
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-11-19
Date Mfgr Received2020-03-16
Device Manufacturer Date2019-04-29
Date Added to Maude2020-03-31
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 ContactMR. STEPHEN PERRY
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE, MA
Manufacturer CountryUS
Manufacturer Phone6604163
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Street333 CONEY STREET
Manufacturer CityEAST WALPOLE, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVIA CENTAUR XPT CA 15-3
Generic NameCA 15-3 IMMUNOASSAY
Product CodeMOI
Date Received2020-03-31
Model NumberN/A
Catalog Number10327620
Lot Number20789179
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS, INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN, NY US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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