ADVIA CENTAUR XP 078-A010-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-18 for ADVIA CENTAUR XP 078-A010-01 manufactured by Siemens Healthcare Diagnostics, Inc..

Event Text Entries

[5100754] Discordant progesterone results were obtained on multiple patient samples on an advia centaur xp instrument. The initial results were reported to the physician(s). The samples were repeated on the same system. The corrected results were reported to the physician(s). There are no known reports of adverse health consequences or patient intervention due to the discordant progesterone results.
Patient Sequence No: 1, Text Type: D, B5


[12493434] A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse determined that the aspirate 1 valve malfunctioned. The cse replaced the aspirate 1 valve and successfully ran quality controls. The cause of the discordant progesterone results is due to the aspirate 1 valve malfunction. The customer successfully recalibrated the progesterone assay. The instrument is performing within specifications. Further evaluation of the device is not required.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2432235-2014-00607
MDR Report Key4183324
Report Source05,06
Date Received2014-10-18
Date of Report2014-09-24
Date of Event2014-09-24
Date Mfgr Received2014-09-24
Device Manufacturer Date2007-10-12
Date Added to Maude2014-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJOHN NELSON
Manufacturer Street511 BENEDICT AVENUE
Manufacturer CityTARRYTOWN NY 10591
Manufacturer CountryUS
Manufacturer Postal10591
Manufacturer Phone9145242530
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 Details

Brand NameADVIA CENTAUR XP
Generic NameIMMUNOASSAY ANALYZER
Product CodeJLX
Date Received2014-10-18
Model NumberADVIA CENTAUR XP
Catalog Number078-A010-01
ID NumberN/A
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 2014-10-18

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