ADVIA CENTAUR XP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-02-06 for ADVIA CENTAUR XP manufactured by Siemens Healthcare Diagnostics Inc..

Event Text Entries

[66668182] The customer contacted the siemens customer care center (ccc). The customer stated that they had observed erratic patient and quality control (qc) results and the cea assay was failing calibration. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument, the cse performed a total service visit and found aspirate probe 1 was not aspirating. The cse replaced the aspirate probe and tested it. The cse cleaned the bottom of the main manifold and ran and empty and fill of cuvettes. The cse ran quality control (qc), resulting satisfactory. The cause of the discordant, falsely elevated cea results is unknown. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10


[66668183] Discordant, falsely elevated carcinoembryonic antigen (cea) results were obtained on patient samples on an advia centaur xp instrument. The discordant results were reported to the physician(s) who questioned them, as the results did not align with previous results from the patients. The patient samples were repeated and results were similar to the previous results from the patients. There are no known reports of patient intervention or adverse health consequences due to discordant, falsely elevated cea results.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2432235-2017-00099
MDR Report Key6305599
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-02-06
Date of Report2017-02-06
Date of Event2017-01-10
Date Mfgr Received2017-01-12
Device Manufacturer Date2015-08-24
Date Added to Maude2017-02-06
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 ContactMS. CASSANDRA KOCSIS
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242687
Manufacturer G1SIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer StreetMANUFACTURING LIMITED REGISTRATION NUMBER: 8020888
Manufacturer CityCHAPEL LANE, DUBLIN, SWORDS,
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 0

Brand NameADVIA CENTAUR XP
Generic NameIMMUNOASSAY ANALYZER
Product CodeDHX
Date Received2017-02-06
Model NumberADVIA CENTAUR XP
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No0
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591

Device Sequence Number: 1

Brand NameADVIA CENTAUR XP
Generic NameIMMUNOASSAY ANALYZER
Product CodeJJE
Date Received2017-02-06
Model NumberADVIA CENTAUR XP
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSIEMENS HEALTHCARE DIAGNOSTICS INC.
Manufacturer Address511 BENEDICT AVENUE TARRYTOWN NY 10591 US 10591


Patients

Patient NumberTreatmentOutcomeDate
10 2017-02-06

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