ADVIA CENTAUR XPT

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 2017-12-21 for ADVIA CENTAUR XPT manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[95962662] The cause of the discordant, falsely elevated afp result on one patient sample is unknown. Siemens is investigating the issue. Mdr 2432235-2017-00531_s3 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00599_s1 was filed for the event occurred on (b)(6) 2017. Mdr 2432235-2017-00625_s1 was filed for the event occurred on (b)(6) 2017.
Patient Sequence No: 1, Text Type: N, H10


[95962663] A discordant, falsely elevated alpha-fetoprotein (afp) result was obtained on one patient sample on an advia centaur xpt instrument. The sample was repeated twice on the same instrument, resulting lower both times. One of the repeat results was reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely elevated afp result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2017-00660
MDR Report Key7139652
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2017-12-21
Date of Report2018-07-23
Date of Event2017-12-01
Date Mfgr Received2018-05-07
Device Manufacturer Date2016-11-07
Date Added to Maude2017-12-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSHWETA GULATI
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242870
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS
Manufacturer StreetMANUFACTURING LIMITED REGISTRATION NUMBER: 8020888
Manufacturer CityCHAPEL LANE, SWORDS, CO., DUBLIN
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameADVIA CENTAUR XPT
Generic NameIMMUNOASSAY ANALYZER
Product CodeLOJ
Date Received2017-12-21
Model NumberADVIA CENTAUR XPT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVE TARRYTOWN NY 10591 US 10591

Device Sequence Number: 1

Brand NameADVIA CENTAUR XPT
Generic NameIMMUNOASSAY ANALYZER
Product CodeJJE
Date Received2017-12-21
Model NumberADVIA CENTAUR XPT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-21

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